UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Month of May 2024
(Commission File No. 001-41636)
Oculis Holding AG
(Translation of registrant's name into English)
Bahnhofstrasse 7
CH-6300
Zug, Switzerland
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On May 8, 2024, Oculis Holding AG (the “Registrant”) announced its unaudited results for the three months ended March 31, 2024, which are further described in the Registrant’s Unaudited Condensed Consolidated Interim Financial Statements, Management’s Discussion and Analysis of Financial Condition and Results of Operations and press release, copies of which are attached hereto as Exhibits 99.1, 99.2 and 99.3, respectively, and are incorporated by reference herein.
The information contained in this Form 6-K, including Exhibits 99.1 and 99.2 but excluding Exhibit 99.3, is hereby incorporated by reference into the Registrant’s Registration Statements on Form S-8 (File No. 333-271938) and Form F-3 (333-271063 and 333-278409).
EXHIBIT INDEX
Exhibit |
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Description |
99.1 |
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99.2 |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
99.3 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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OCULIS HOLDING AG |
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Date: May 8, 2024 |
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By: |
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/s/ Sylvia Cheung |
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Sylvia Cheung Chief Financial Officer |
Exhibit 99.1
Oculis Holding AG
Unaudited Condensed Consolidated Interim Financial Statements
2
Oculis Holding AG, Zug
Unaudited Condensed Consolidated Interim Statements of Financial Position
(in CHF thousands)
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As of March 31, |
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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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259 |
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288 |
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Intangible assets |
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6 |
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12,206 |
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12,206 |
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Right-of-use assets |
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719 |
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755 |
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Other non-current assets |
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87 |
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89 |
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Total non-current assets |
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13,271 |
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13,338 |
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Current assets |
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Other current assets |
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8 |
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4,371 |
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8,488 |
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Accrued income |
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8 |
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1,138 |
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876 |
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Short-term financial assets |
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10 |
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55,572 |
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53,324 |
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Cash and cash equivalents |
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10 |
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24,361 |
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38,327 |
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Total current assets |
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85,442 |
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101,015 |
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TOTAL ASSETS |
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98,713 |
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114,353 |
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EQUITY AND LIABILITIES |
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Shareholders' equity |
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Share capital |
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367 |
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366 |
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Share premium |
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288,387 |
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288,162 |
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Reserve for share-based payment |
|
9 |
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7,520 |
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6,379 |
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Actuarial loss on post-employment benefit obligations |
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(1,072 |
) |
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(1,072 |
) |
Cumulative translation adjustments |
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(296 |
) |
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(327 |
) |
Accumulated losses |
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(215,873 |
) |
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(199,780 |
) |
Total equity |
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79,033 |
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93,728 |
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Non-current liabilities |
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Long-term lease liabilities |
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411 |
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431 |
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Long-term payables |
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378 |
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378 |
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Defined benefit pension liabilities |
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738 |
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728 |
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Total non-current liabilities |
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1,527 |
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1,537 |
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Current liabilities |
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Trade payables |
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1,174 |
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7,596 |
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Accrued expenses and other payables |
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12 |
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8,358 |
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5,948 |
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Short-term lease liabilities |
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182 |
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174 |
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Warrant liabilities |
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11 |
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8,439 |
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5,370 |
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Total current liabilities |
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18,153 |
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19,088 |
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Total liabilities |
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19,680 |
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20,625 |
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TOTAL EQUITY AND LIABILITIES |
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98,713 |
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114,353 |
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The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.
3
Oculis Holding AG, Zug
Unaudited Condensed Consolidated Interim Statements of Loss
(in CHF thousands, except loss per share data)
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For the three months ended March 31, |
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Note |
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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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222 |
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229 |
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Operating income |
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222 |
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229 |
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Research and development expenses |
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7. (B) |
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(10,856 |
) |
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(6,148 |
) |
General and administrative expenses |
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7. (B) |
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(4,694 |
) |
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(4,042 |
) |
Merger and listing expense |
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2 / 7. (B) |
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- |
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(34,863 |
) |
Operating expenses |
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(15,550 |
) |
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(45,053 |
) |
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Operating loss |
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(15,328 |
) |
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(44,824 |
) |
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Finance income |
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7. (C) |
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581 |
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33 |
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Finance expense |
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7. (C) |
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(41 |
) |
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(1,279 |
) |
Fair value adjustment on warrant liabilities |
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7. (C) / 11 |
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(3,069 |
) |
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422 |
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Foreign currency exchange gain (loss) |
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7. (C) |
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1,794 |
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(243 |
) |
Finance result |
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(735 |
) |
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(1,067 |
) |
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Loss before tax for the period |
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(16,063 |
) |
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(45,891 |
) |
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Income tax expense |
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(30 |
) |
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(124 |
) |
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Loss for the period |
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(16,093 |
) |
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(46,015 |
) |
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Loss per share: |
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Basic and diluted loss attributable to equity holders |
|
15 |
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(0.44 |
) |
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(3.57 |
) |
The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.
4
Oculis Holding AG, Zug
Unaudited Condensed Consolidated Interim Statements of Comprehensive Loss
(in CHF thousands)
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For the three months ended March 31, |
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|
2024 |
|
2023 |
Loss for the period |
|
(16,093) |
|
(46,015) |
|
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Other comprehensive profit/(loss): |
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Items that will not be reclassified to profit or loss: |
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Actuarial gains/(losses) of defined benefit plans |
|
- |
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(53) |
Items that may be reclassified subsequently to profit or loss: |
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Foreign currency translation differences |
|
31 |
|
(1,994) |
Other comprehensive profit/(loss) for the period |
|
31 |
|
(2,047) |
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Total comprehensive loss for the period |
|
(16,062) |
|
(48,062) |
The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.
5
Oculis Holding AG, Zug
Unaudited Condensed Consolidated Interim Statements of Changes in Equity
(in CHF thousands, except share numbers)
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Legacy Oculis share capital |
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Legacy Oculis treasury shares |
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Oculis share capital |
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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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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 December 31, 2022 (as previously reported) |
|
|
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3,406,771 |
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|
340 |
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|
|
(100,000 |
) |
|
|
(100 |
) |
|
|
|
- |
|
|
|
- |
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|
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10,540 |
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|
2,771 |
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(300 |
) |
|
|
(264 |
) |
|
|
(110,978 |
) |
|
|
(97,991 |
) |
Retroactive application of the recapitalization due to the business combination |
|
2 |
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|
487,951 |
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(301 |
) |
|
|
(14,323 |
) |
|
|
99 |
|
|
|
|
- |
|
|
|
- |
|
|
|
202 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Balance as of January 1, 2023 (effect of the recapitalization) |
|
|
|
|
3,894,722 |
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|
39 |
|
|
|
(114,323 |
) |
|
|
(1 |
) |
|
|
|
- |
|
|
|
- |
|
|
|
10,742 |
|
|
|
2,771 |
|
|
|
(300 |
) |
|
|
(264 |
) |
|
|
(110,978 |
) |
|
|
(97,991 |
) |
Loss for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(46,015 |
) |
|
|
(46,015 |
) |
Other comprehensive profit: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Actuarial gain on post-employment benefit obligations |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(53 |
) |
|
|
- |
|
|
|
(53 |
) |
Foreign currency translation differences |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,994 |
) |
|
|
- |
|
|
|
- |
|
|
|
(1,994 |
) |
Total comprehensive loss for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,994 |
) |
|
|
(53 |
) |
|
|
(46,015 |
) |
|
|
(48,062 |
) |
Share-based compensation expense |
|
9 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
145 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
145 |
|
Conversion of Legacy Oculis ordinary shares and treasury shares into Oculis ordinary shares |
|
2 |
|
|
(3,894,722 |
) |
|
|
(39 |
) |
|
|
114,323 |
|
|
|
1 |
|
|
|
|
3,780,399 |
|
|
|
38 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Conversion of Legacy Oculis long-term financial debt into Oculis ordinary shares |
|
2 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
16,496,603 |
|
|
|
165 |
|
|
|
124,637 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
124,802 |
|
Issuance of ordinary shares to PIPE investors |
|
2 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
7,118,891 |
|
|
|
71 |
|
|
|
66,983 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
67,054 |
|
Issuance of ordinary shares under CLA |
|
2 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
1,967,000 |
|
|
|
20 |
|
|
|
18,348 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
18,368 |
|
Issuance of ordinary shares to EBAC shareholders |
|
2 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
3,370,480 |
|
|
|
33 |
|
|
|
35,492 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
35,525 |
|
Transaction costs related to the business combination |
|
2 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
(4,997 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(4,997 |
) |
Balance as of March 31, 2023 |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
32,733,373 |
|
|
|
327 |
|
|
|
251,205 |
|
|
|
2,916 |
|
|
|
(2,294 |
) |
|
|
(317 |
) |
|
|
(156,993 |
) |
|
|
94,844 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Balance as of January 1, 2024 |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
36,649,705 |
|
|
|
366 |
|
|
|
288,162 |
|
|
|
6,379 |
|
|
|
(327 |
) |
|
|
(1,072 |
) |
|
|
(199,780 |
) |
|
|
93,728 |
|
Loss for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(16,093 |
) |
|
|
(16,093 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Foreign currency translation differences |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
31 |
|
|
|
- |
|
|
|
- |
|
|
|
31 |
|
Total comprehensive loss for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
31 |
|
|
|
- |
|
|
|
(16,093 |
) |
|
|
(16,062 |
) |
Share-based compensation expense |
|
9 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,141 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,141 |
|
Stock options exercised |
|
9 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
90,590 |
|
|
|
1 |
|
|
|
225 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
226 |
|
Balance as of March 31, 2024 |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
36,740,295 |
|
|
|
367 |
|
|
|
288,387 |
|
|
|
7,520 |
|
|
|
(296 |
) |
|
|
(1,072 |
) |
|
|
(215,873 |
) |
|
|
79,033 |
|
The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.
6
Oculis Holding AG, Zug
Unaudited Condensed Consolidated Interim Statements of Cash Flows
(in CHF thousands)
|
|
|
|
For the three months ended March 31, |
||
|
|
Note |
|
2024 |
|
2023 |
Operating activities |
|
|
|
|
|
|
Loss before tax for the period |
|
|
|
(16,063) |
|
(45,891) |
|
|
|
|
|
|
|
Non-cash adjustments: |
|
|
|
|
|
|
- Financial result |
|
|
|
(1,695) |
|
2,028 |
- Depreciation of property and equipment |
|
|
|
29 |
|
35 |
- Depreciation of right-of-use assets |
|
|
|
44 |
|
28 |
- Share-based compensation expense |
|
9 |
|
1,141 |
|
145 |
- Interest expense on Series B and C preferred shares |
|
|
|
- |
|
1,266 |
- Interests on lease liabilities |
|
|
|
9 |
|
10 |
- Post-employment (benefits)/loss |
|
|
|
10 |
|
(37) |
- Non-realized foreign exchange differences |
|
|
|
24 |
|
54 |
- Fair value adjustment on warrant liabilities |
|
11 |
|
3,069 |
|
(422) |
- Merger and listing expense |
|
2 |
|
- |
|
34,863 |
Working capital adjustments: |
|
|
|
|
|
|
- De/(Increase) in other current assets |
|
8 |
|
4,135 |
|
94 |
- De/(Increase) in accrued income |
|
8 |
|
(262) |
|
(254) |
- (De)/Increase in trade payables |
|
|
|
(6,422) |
|
(2,157) |
- (De)/Increase in accrued expenses and other payables |
|
12 |
|
2,271 |
|
(5,389) |
- (De)/Increase in other operating assets/liabilities |
|
|
|
- |
|
(16) |
|
|
|
|
|
|
|
Interest received |
|
|
|
535 |
|
37 |
Interest paid |
|
|
|
(10) |
|
(13) |
Taxes paid |
|
|
|
(10) |
|
- |
Net cash outflow from operating activities |
|
|
|
(13,195) |
|
(15,619) |
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
Payment for short-term financial assets, net |
|
10 |
|
(2,047) |
|
- |
Net cash outflow from investing activities |
|
|
|
(2,047) |
|
- |
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
Proceeds from the shares issued to PIPE investors |
|
2 |
|
- |
|
67,054 |
Proceeds from the shares issued to CLA investors |
|
2 |
|
- |
|
18,368 |
Proceeds from EBAC non-redeemed shareholders |
|
2 |
|
- |
|
12,014 |
Transaction costs related to the business combination |
|
2 |
|
- |
|
(2,139) |
Proceeds from stock options exercised |
|
9 |
|
226 |
|
- |
Principal payment of lease obligation |
|
|
|
(45) |
|
(27) |
Net cash inflow from financing activities |
|
|
|
181 |
|
95,270 |
|
|
|
|
|
|
|
Increase/(Decrease) in cash and cash equivalents |
|
|
|
(15,061) |
|
79,651 |
|
|
|
|
|
|
|
Cash and cash equivalents, beginning of period |
|
10 |
|
38,327 |
|
19,786 |
Effect of foreign exchange rate changes |
|
|
|
1,095 |
|
(2,985) |
Cash and cash equivalents, end of period |
|
10 |
|
24,361 |
|
96,452 |
|
|
|
|
|
|
|
Net cash and cash equivalents variation |
|
|
|
(15,061) |
|
79,651 |
|
|
|
|
|
|
|
Supplemental non-cash financing information |
|
|
|
|
|
|
Transaction costs recorded in accrued expenses and other payables |
|
|
|
435 |
|
2,624 |
The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.
7
Oculis Holding AG, Zug
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 March 31, 2024, the Company controlled six 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, Oculis HK, Limited (“Oculis HK”) which was incorporated in Hong Kong, China on June 1, 2021 and Oculis Merger Sub II Company (“Merger Sub 2”) which was incorporated in the Cayman Islands on January 3, 2023 and subsequently dissolved on April 18, 2024. The Company and its wholly-owned subsidiaries form the Oculis Group (the “Group”). Prior to the Business Combination (as defined in Note 2), 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.
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, 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.
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 97.6 million or $103.7 million, comprising CHF 12.0 million or $12.8 million of cash held in EBAC’s trust account and CHF 85.6 million or $90.9 million from private placement (“PIPE”) investments and conversion of notes issued under Convertible Loan Agreements (“CLA”) into Oculis' ordinary shares. In connection with the Business Combination, Oculis was listed on the Nasdaq Global Market with the ticker symbol “OCS” for its ordinary shares and “OCSAW” for its public warrants.
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 7,118,891 shares of EBAC Class A ordinary shares at CHF 9.42 or $10.00 per share for aggregate gross proceeds of CHF 67.1 million or $71.2 million.
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 1,967,000 ordinary shares at CHF 9.42 or $10.00 per share for aggregate gross proceeds of CHF 18.5 million or $19.7 million.
Together, the PIPE and CLA financing resulted in aggregate gross cash proceeds of CHF 85.6 million or $90.9 million to Oculis in exchange for 9,085,891 ordinary shares.
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 34.9 million, which was expensed to the statement of loss as operating expenses, “Merger and listing expense”. The expense is non-recurring in nature and represented a share-based payment made in exchange for a listing service and does not lead to any cash outflows.
Earnout consideration
As a result of the BCA, Legacy Oculis preferred, ordinary and option holders (collectively “equity holders”) received consideration in the form of 3,793,995 earnout shares and 369,737 earnout options with an exercise price of CHF 0.01.
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) 1,500,000, (ii) 1,500,000 and (iii) 1,000,000 earned based on the achievement of post-acquisition closing share price targets of Oculis of $15.00,
8
$20.00 and $25.00, respectively, in each case, for any 20 trading days within any consecutive 30 trading day period commencing after the acquisition closing date and ending on or prior to March 2, 2028 (the “Earnout period”). A given share price target described above will also be deemed to be achieved if there is a change of control, as defined in the BCA, transaction of Oculis during the earnout period.
Public offering of ordinary shares
On June 5 and June 13, 2023, the Company closed the issuance and sale in a public offering of 3,654,234 ordinary shares at a public offering price of CHF 10.45 or $11.50 per share, for total gross proceeds of CHF 38.2 million or $42.0 million before deducting underwriting discounts, commissions and offering expenses.
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 Icelandic financing transaction discussed in Note 17 “Subsequent Events”, 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. Inherent to the Company’s business are various risks and uncertainties, 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 March 31, 2024 and for the three months ended March 31, 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 to consummation of 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 2, Oculis issued 3,780,399 ordinary shares to Legacy Oculis shareholders in exchange for 3,306,771 Legacy Oculis ordinary shares (after cancellation of 100,000 Legacy Oculis treasury shares) at the Exchange Ratio. The number of ordinary shares, and the number of ordinary shares within the loss per share held by the shareholders prior to the Business Combination have been adjusted by the Exchange Ratio to reflect the equivalent number of ordinary shares in the Company.
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 exchange rates. The exchange differences arising on translation for consolidation are recognized in other comprehensive income.
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.
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.
9
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 are relevant to the Group and that have had any 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.
The Company is managed and operated as one business. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business and accordingly, the Company has one reporting segment.
The table below provides the carrying amount of certain non-current assets, by geographic area:
in CHF thousands |
|
Switzerland |
|
|
Iceland |
|
|
Others |
|
|
Total |
|
||||||||||||||||||||
|
|
As of March 31, 2024 |
|
|
As of December 31, 2023 |
|
|
As of March 31, 2024 |
|
|
As of December 31, 2023 |
|
|
As of March 31, 2024 |
|
|
As of December 31, 2023 |
|
|
As of March 31, 2024 |
|
|
As of December 31, 2023 |
|
||||||||
Intangible assets |
|
|
12,206 |
|
|
|
12,206 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
12,206 |
|
|
|
12,206 |
|
Property and equipment, net |
|
|
14 |
|
|
|
17 |
|
|
|
227 |
|
|
|
253 |
|
|
|
18 |
|
|
|
18 |
|
|
|
259 |
|
|
|
288 |
|
Right-of-use assets |
|
|
- |
|
|
|
- |
|
|
|
661 |
|
|
|
687 |
|
|
|
58 |
|
|
|
68 |
|
|
|
719 |
|
|
|
755 |
|
Total |
|
|
12,220 |
|
|
|
12,223 |
|
|
|
888 |
|
|
|
940 |
|
|
|
76 |
|
|
|
86 |
|
|
|
13,184 |
|
|
|
13,249 |
|
Intangible assets as of March 31, 2024 and as of December 31, 2023 were CHF 12.2 million and represent licenses purchased under license agreements with Novartis and Accure. The Novartis license agreement was dated as of December 19, 2018 between Oculis and Novartis and relates to a novel topical anti-TNFα antibody, renamed OCS-02 (Licaminlimab), for ophthalmic indications. The license agreement between Oculis and Accure, dated as of January 29, 2022, relates to the exclusive global licensing of its OCS-05 (formerly ACT-01) technology. The Company intends to advance the development of OCS-05 with a focus on multiple ophthalmology neuroprotective applications.
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 months ended March 31, 2024 and 2023 was CHF 0.2 million.
The tables below show the breakdown of the Operating expenses by category:
in CHF thousands |
|
For the three months ended March 31, |
|
|||||||||||||||||||||
|
|
Research and development expenses |
|
|
General and administrative expenses |
|
|
Total operating expenses |
|
|||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||||
Personnel expense |
|
|
1,736 |
|
|
|
1,124 |
|
|
|
2,236 |
|
|
|
1,193 |
|
|
|
3,972 |
|
|
|
2,317 |
|
Payroll |
|
|
1,285 |
|
|
|
1,076 |
|
|
|
1,546 |
|
|
|
1,096 |
|
|
|
2,831 |
|
|
|
2,172 |
|
Share-based compensation |
|
|
451 |
|
|
|
48 |
|
|
|
690 |
|
|
|
97 |
|
|
|
1,141 |
|
|
|
145 |
|
Operating expenses |
|
|
9,120 |
|
|
|
5,024 |
|
|
|
2,458 |
|
|
|
2,849 |
|
|
|
11,578 |
|
|
|
7,873 |
|
External service providers |
|
|
8,971 |
|
|
|
4,902 |
|
|
|
1,816 |
|
|
|
1,510 |
|
|
|
10,787 |
|
|
|
6,412 |
|
Other operating expenses |
|
|
94 |
|
|
|
66 |
|
|
|
624 |
|
|
|
1,332 |
|
|
|
718 |
|
|
|
1,398 |
|
Depreciation of property and equipment |
|
|
25 |
|
|
|
28 |
|
|
|
4 |
|
|
|
7 |
|
|
|
29 |
|
|
|
35 |
|
Depreciation of right-of-use assets |
|
|
30 |
|
|
|
28 |
|
|
|
14 |
|
|
|
- |
|
|
|
44 |
|
|
|
28 |
|
Merger and listing expense(1) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
34,863 |
|
|
Total |
|
|
10,856 |
|
|
|
6,148 |
|
|
|
4,694 |
|
|
|
4,042 |
|
|
|
15,550 |
|
|
|
45,053 |
|
(1) Merger and listing expense is presented separately from research and development or general and administrative expenses on the unaudited condensed consolidated statements of loss. The item relates to the BCA and is non-recurring in nature, representing a share-based payment made in exchange for a listing service.
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, mainly the ongoing OCS-01 DME DIAMOND-1 and DIAMOND-2 Phase 3 Stage 2 clinical trials, OPTIMIZE-2 Phase 3 clinical trial and OCS-02 RELIEF Phase 2b clinical trial.
10
The table below shows the breakdown of the finance result by category:
in CHF thousands |
For the three months ended March 31, |
|
|||||
|
2024 |
|
|
2023 |
|
||
Finance income |
|
581 |
|
|
|
33 |
|
Finance expense |
|
(41 |
) |
|
|
(1,279 |
) |
Fair value adjustment on warrant liabilities |
|
(3,069 |
) |
|
|
422 |
|
Foreign currency exchange gain (loss) |
|
1,794 |
|
|
|
(243 |
) |
Finance result |
|
(735 |
) |
|
|
(1,067 |
) |
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 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 2).
Finance income 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 gain/(loss) on warrant liabilities. The foreign currency exchange gain (loss) is primarily related to fluctuations of U.S. dollar and Euro against Swiss Franc impacting our cash and short-term financial assets balances. In 2024 the U.S. dollar strengthened against the Swiss Franc leading to foreign exchange gains on short term financial assets and cash balances, whereas 2023 foreign exchange loss mainly related to the revaluation of the U.S. dollar-denominated long-term liability.
The table below shows the breakdown of the Other current assets by category:
in CHF thousands |
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||
Prepaid clinical and technical development expenses |
|
|
3,026 |
|
|
|
6,748 |
|
Prepaid general and administrative expenses |
|
|
1,165 |
|
|
|
1,412 |
|
VAT receivable |
|
|
180 |
|
|
|
328 |
|
Total |
|
|
4,371 |
|
|
|
8,488 |
|
The decrease in prepaid clinical and technical development expenses as of March 31, 2024 compared to prior quarter relates to the commencement of significant clinical trials in the fourth quarter of 2023 accompanied by significant start up fees invoices.
The table below shows the movement of the Accrued income for the three months ended March 31, 2024 and 2023:
in CHF thousands |
|
2024 |
|
|
2023 |
|
||
Balance as of January 1, |
|
|
876 |
|
|
|
912 |
|
Accrued income recognized during the period |
|
|
222 |
|
|
|
229 |
|
Foreign exchange revaluation |
|
|
40 |
|
|
|
24 |
|
Balance as of March 31, |
|
|
1,138 |
|
|
|
1,165 |
|
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 SARs granted in equity. For each grant of share-based options or SARs, the Company issues a grant notice, which details the 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 awards granted during the three months ended March 31, 2024 was CHF 8.36 or $9.56 per share. The weighted average grant date fair value for awards granted during the three months ended March 31, 2023 was CHF 4.68 or $5.12 per share.
11
The Black-Scholes fair value of SARs was determined using assumptions that were not materially different from those used to value options. The following assumptions were used in the Black-Scholes option pricing model for determining the value of options and SARs granted during the three months ended March 31, 2024 and 2023:
|
|
For the three months ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Weighted average share price at the date of grant (1) |
|
USD 12.16 (CHF 10.63) |
|
|
USD 7.85 (CHF 7.18) |
|
||
Expected volatility (%) (2) |
|
|
93.00 |
|
|
|
68.70 |
|
Expected term (years) (3) |
|
6.25 |
|
|
6.25 |
|
||
Range of risk-free interest rate (%) (1)(4) |
|
3.91-4.30 |
|
|
|
3.53 |
|
|
Dividend yield (%) |
|
|
0.00 |
|
|
|
0.00 |
|
(1) Following the NASDAQ listing, the equity award exercise price is denominated in USD and the applicable risk-free interest rate has been adjusted accordingly.
(2) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company’s industry.
(3) The expected term represents the period that share-based awards are 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 term.
The following table summarizes the Company’s stock option and SAR activity under the 2023 ESOP for the three months ending March 31, 2024 and 2023:
|
|
For the three months ended March 31, 2024 |
|
For the three months ended March 31, 2023 |
||||||||
|
|
Number of awards (1) |
|
Weighted average exercise price (1) (CHF) |
|
Range of expiration dates |
|
Number of awards (1) |
|
Weighted average exercise price (1) (CHF) |
|
Range of expiration dates |
Outstanding as of January 1, |
|
3,466,210 |
|
4.50 |
|
2027-2033 |
|
1,762,949 |
|
2.39 |
|
2027-2031 |
Options granted(2) |
|
270,582 |
|
10.63 |
|
2034 |
|
1,449,500 |
|
7.18 |
|
2028-2033 |
SARs granted |
|
— |
|
— |
|
— |
|
134,765 |
|
7.18 |
|
2033 |
Earnout options granted |
|
— |
|
— |
|
— |
|
369,737 |
|
0.01 |
|
2028 |
Forfeited(3) |
|
(55,928) |
|
6.80 |
|
2032-2033 |
|
— |
|
— |
|
— |
Exercised(3) |
|
(90,590) |
|
2.50 |
|
2027-2032 |
|
— |
|
— |
|
— |
Outstanding as of March 31, |
|
3,590,274 |
|
4.96 |
|
2028-2034 |
|
3,716,951 |
|
4.19 |
|
2027-2033 |
(1) Retroactive application of the recapitalization effect due to the BCA, the Exchange Ratio was applied to the number of awards and the weighted average exercise price was divided by the same exchange ratio.
(2) Pursuant to the BCA, all outstanding and unexercised options to purchase Legacy Oculis ordinary shares were assumed by Oculis and each option was replaced by an option to purchase ordinary shares of Oculis (the “Converted Options”). The exchange of Legacy Oculis 2018 Plan options for converted 2023 Plan options is not reflected in the table above. Refer to Note 2 - Business Combination and Financing Activities for further details.
(3) Forfeited amount includes earnout options forfeited during the quarters ended March 31, 2024 and 2023. No SARs had been exercised or forfeited during the quarters ended March 31, 2024 and 2023.
The number of options that were exercisable at March 31, 2024 and 2023 were 1,482,230 and 998,703, respectively. Excluding earnout options, which have an exercise price of CHF 0.01, options outstanding as of March 31, 2024 have exercise prices ranging from CHF 1.76 to CHF 11.91. The weighted average remaining contractual life of options and SARs outstanding as of March 31, 2024 and December 31, 2023 was eight years.
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 are granted and expensed at fair value. No restricted shares were awarded under the 2023 ESOP during the three months ended March 31, 2024 and 2023. As of March 31, 2024, 1,125,624 restricted shares were not subject to repurchase out of total 1,186,932 restricted shares exercised, compared to 1,088,838 as of December 31, 2023.
Share-based compensation expense
The total expense recognized in the statement of loss for share options granted amounted to CHF 1.1 million for the three months ended March 31, 2024 and CHF 0.1 million for the three months ended March 31, 2023. The reserve for share-based payment increased from CHF 6.4 million as of December 31, 2023 to CHF 7.5 million as of March 31, 2024.
Earnout options
As a result of the BCA, Legacy Oculis preferred, ordinary and option holders (collectively “equity holders”) received consideration in the form of 3,793,995 Earnout shares and 369,737 Earnout options with an exercise price of CHF 0.01. As of March 31, 2024 the price targets had not yet been achieved. Refer to Note 2.
The table below shows the breakdown of the cash and cash equivalents and short-term financial assets by currencies:
12
in CHF thousands |
|
Cash and cash equivalents |
|
|
Short-term financial assets |
|
||||||||||
by currency |
|
As of March 31, 2024 |
|
|
As of December 31, 2023 |
|
|
As of March 31, 2024 |
|
|
As of December 31, 2023 |
|
||||
Swiss Franc |
|
|
5,157 |
|
|
|
19,144 |
|
|
|
45,532 |
|
|
|
33,532 |
|
US Dollar |
|
|
15,128 |
|
|
|
16,610 |
|
|
|
9,016 |
|
|
|
15,148 |
|
Euro |
|
|
3,907 |
|
|
|
2,020 |
|
|
|
1,024 |
|
|
|
4,644 |
|
Iceland Krona |
|
|
146 |
|
|
|
542 |
|
|
|
- |
|
|
|
- |
|
Other |
|
|
23 |
|
|
|
11 |
|
|
|
- |
|
|
|
- |
|
Total |
|
|
24,361 |
|
|
|
38,327 |
|
|
|
55,572 |
|
|
|
53,324 |
|
Short-term financial assets consist of fixed term bank deposits with maturities between three and six months.
As of March 2, 2023, the Company recognized the warrant liabilities at fair value of CHF 2.1 million. For the three months ended March 31, 2024, the Company recognized a fair value loss in the unaudited condensed interim statement of loss of CHF 3.1 million leading to an increase of the warrant liability to CHF 8.4 million as of March 31, 2024 due to higher share price. There were no warrant exercises during the three months ended March 31, 2024 and 2023.
The fair value of the public warrants traded in active markets is based on the quoted market prices at the end of the reporting period for such warrants. Since the private placement warrants have identical terms to the public warrants, the Company determined that the fair value of each private placement warrant is equivalent to that of each public warrant. Public warrant instruments are included in Level 1 and private warrants in Level 2 in the fair value hierarchy. Warrants were classified as short-term liabilities given the Company cannot defer the settlement for at least 12 months.
The movement of the warrant liability is illustrated below:
|
2024 |
|
|
2023 |
|
||||||||||
in CHF thousands (except number of warrants) |
Warrant liabilities |
|
|
Number of outstanding public and private warrants |
|
|
Warrant liabilities |
|
|
Number of outstanding public and private warrants |
|
||||
Balance as of January 1, |
|
5,370 |
|
|
|
4,254,096 |
|
|
|
- |
|
|
|
- |
|
Issuance of warrants |
|
- |
|
|
|
- |
|
|
|
2,136 |
|
|
|
4,403,294 |
|
Fair value (gain)/loss on warrant liability |
|
3,069 |
|
|
|
- |
|
|
|
(422 |
) |
|
|
- |
|
Balance as of March 31, |
|
8,439 |
|
|
|
4,254,096 |
|
|
|
1,714 |
|
|
|
4,403,294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
The table below shows the breakdown of the Accrued expenses and other payables by category:
in CHF thousands |
|