6-K

 

 

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 March 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 March 18, 2024, Oculis Holding AG (the “Registrant”) issued a press release announcing its financial results for the fiscal year ended December 31, 2023. Copies of the press release, the Registrant’s 2023 IFRS consolidated financial statements, 2023 Statutory Financial Statements and 2023 Compensation Report are furnished as Exhibits 99.1, 99.2, 99.3 and 99.4, respectively, to this Report on Form 6-K.

 

 

 

EXHIBIT INDEX

 

Exhibit

Description

99.1

 

Press Release dated March 18, 2024

99.2

 

IFRS consolidated financial statements as of and for the year ended December 31, 2023

99.3

 

Statutory Financial Statements of Oculis Holding AG for the period October 31, 2022 - December 31, 2023

99.4

 

Compensation Report 2023 of Oculis Holding AG

 


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.

 

 

 

OCULIS HOLDING AG

 

 

 

 

Date: March 19, 2024

 

By:

/s/ Riad Sherif

 

 

 

Chief Executive Officer

 


EX-99.1

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Exhibit 99.1

 

Oculis Reports Q4 and Full Year 2023 Financial Results and Update on Company Progress

 

A successful year including NASDAQ listing and positive results from two Phase 3 programs in OCS-01: Phase 3 Stage 1 DIAMOND trial for Diabetic Macular Edema (DME), and Phase 3 OPTIMIZE-1 trial for inflammation and pain following cataract surgery
On-track to report topline data from OCS-02 (Licaminlimab) Phase 2b RELIEF trial in Dry Eye Disease (DED) in Q2 2024, OCS-01 Phase 3 OPTIMIZE-2 trial, and OCS-05 proof-of-concept ACUITY trial in Q4 2024
Cash, cash equivalents and short-term investments of $108.9 million funding operations and planned clinical trials, as well as advancements in DIAMOND-1 and DIAMOND-2 Phase 3 trials
R&D Day held on February 28, 2024, showcasing OCS-01 DME and OCS-02 DED and their transformative treatment potentials

 

ZUG, Switzerland, and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced fourth quarter and full year financial results for the period ended December 31, 2023, and an overview of the Company’s progress.

 

Riad Sherif M.D., Chief Executive Officer of Oculis:

 

“2023 was a remarkable milestone-rich year for Oculis. Following our listing on NASDAQ, we had two positive Phase 3 data readouts with OCS-01, the first topical candidate with compelling data in DME, and achieved a strong close of the year with the initiation of three clinical trials, including the OCS-02 Phase 2b RELIEF trial in DED. As our innovative and diversified pipeline continues to advance, we remain laser-focused on delivering our key programs: OCS-01 in DME, OCS-02 in DED and OCS-05 in Acute Optic Neuritis. We are confident and excited as we move into a catalyst-rich 2024 and look forward to updating everyone on the upcoming RELIEF trial readout planned in Q2, the second Phase 3 OPTIMIZE-2 trial readout of OCS-01 in ocular surgery in Q4, which will allow us to submit our first NDA, in addition to the ACUITY trial readout of OCS-05 in Acute Optic Neuritis, also planned in Q4. I would like to thank our exceptional team and all our partners for their great contribution but also for their commitment towards our mission to save sight and improve eye care.”

 

Q4 2023 and Recent Highlights

 

Advanced OCS-01, a novel high concentration preservative-free topical OPTIREACH® formulation of dexamethasone with the potential to treat both front and back of the eye indications, in three ongoing pivotal trials:
o
In DME, following the positive topline results from Stage 1 of Phase 3 DIAMOND program, the Company announced the first patient first visit in Stage 2 of the first Phase 3 DIAMOND-1 trial and in DIAMOND-2, the second Phase 3 trial required for registration.
o
Following the positive topline results achieved in the Phase 3 OPTIMIZE-1 trial, the Company started the second Phase 3 OPTIMIZE-2 trial of OCS-01 for the treatment of inflammation and pain following cataract surgery.

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Achieved a record completion of patient enrolment for the Phase 2b RELIEF trial of OCS-02 (Licaminlimab), a specifically designed ophthalmic formulation of a TNFα inhibitor, eye drop formulation specifically designed with a proprietary antibody fragment technology to treat ocular inflammation. The trial, initiated in November 2023, is evaluating the efficacy and safety of OCS-02 (Licaminlimab) vs. vehicle in signs of inflammation in DED, and is further exploring its potential unique benefit in patients with a certain genotype (i.e., single-nucleotide polymorphism, SNP, related to the TNF receptor).
Hosted an R&D day on February 28, 2024, with over 100 participants that featured 10 leading experts in retina and anterior segments covering OCS-01 and OCS-02 clinical programs.
Presented the Phase 3 DIAMOND Stage 1 positive results of OCS-01 in DME as late-breaking abstracts at the 23rd EURETINA Congress and at the American Academy of Ophthalmology.

 

Upcoming Clinical Milestones

 

In 2024, the Company is focused on advancing its innovative pipeline and planned clinical development programs including:

 

Q2 2024

OCS-02: The Phase 2b RELIEF trial evaluating topical anti-TNFα OCS-02 (Licaminlimab) efficacy and safety in DED is on track for topline results readout in Q2 2024.

Q4 2024

OCS-01: Topline results from the second Phase 3 OPTIMIZE-2 trial evaluating OCS-01 once daily eye drop for the treatment of inflammation and pain following cataract surgery are anticipated by the end of 2024. If positive, the data from this trial, together with the positive results from the first Phase 3 OPTIMIZE-1 trial, are expected to support the first NDA submission of the Company.
OCS-05: A serum glucocorticoid kinase-2 (SGK-2) activator and potentially disease-modifying neuroprotective candidate is initially being developed for AON. The Phase 2a PoC ACUITY trial is designed to evaluate the safety and tolerability of a once-daily injection of OCS-05 vs. placebo for 5 days, in addition to current standard of care. The trial is on track for topline readout in the fourth quarter of 2024.The Company aims to achieve IND status for OCS-05 in the U.S. in 2024.

 

Q4 and Full Year 2023 Financial Highlights

 

Cash position: As of December 31, 2023, the Company had total cash, cash equivalents and short-term investments of CHF 91.7 million or $108.9 million, compared to CHF 19.8 million or $21.4 million as of December 31, 2022. The increase in cash position reflects proceeds from financing transactions completed in 2023. Based on its current development plans, cash runway is expected to fund operations into late 2025.
Research and development expenses were CHF 8.0 million or $9.0 million for the three-months ended December 31, 2023, compared to CHF 6.9 million or $7.1 million in the same period in 2022. The increase was primarily due to the commencement of three clinical trials during the fourth quarter of 2023: DIAMOND-1 Stage 2, OPTIMIZE-2 and RELIEF.

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General and administrative expenses were CHF 4.3 million or $4.9 million for the three-months ended December 31, 2023. G&A expenses remained in-line with the same period in 2022, which was CHF 4.4 million or $4.6 million.
Q4 Net loss was CHF 12.5 million or $14.1 million for the fourth quarter ended December 31, 2023, compared to CHF 9.2 million or $9.5 million in the fourth quarter of 2022. The increase in net loss was primarily driven by increases in clinical development expenses partially offset by changes in the fair value (non-cash) adjustment of outstanding warrants.
FY2023 Net loss was CHF 88.8 million or $98.8 million for the year ended December 31, 2023, or CHF 2.97 or $3.31 loss per share (basic and diluted) compared to CHF 38.7 million or $40.5 million, or CHF 11.32 or $11.86 loss per share (basic and diluted) in the year ended December 31, 2022. The increase in net loss was primarily driven by the non-recurring merger and listing expense in Q1 2023, increases in clinical development expenses, public company expenses, and the fair value (non-cash) adjustment of outstanding warrants.
FY2023 Non-IFRS net loss was CHF 49.0 million or $54.5 million, or CHF 1.64 or $1.83 per share, for the year ended December 31, 2023, compared to CHF 38.7 million or $40.5 million, or CHF 11.32 or $11.86 per share, for the year ended December 31, 2022. The increase in non-IFRS net loss was primarily driven by increases in clinical development expenses, G&A expenses related to operating as a public company, and an increase in the fair value (non-cash) adjustment of outstanding warrants.

 

Non-IFRS Financial Information

This press release contains financial measures that do not comply with International Financial Reporting Standards (IFRS) including non-IFRS net loss for the full year 2023, and non-IFRS net loss per common share for the same period. These non-IFRS financial measures exclude the impact of items that the Company’s management believes affect comparability or underlying business trends. These measures supplement the Company’s financial results prepared in accordance with IFRS. The Company’s management uses these measures to better analyze its financial results and better estimate its financial outlook. In management’s opinion, these non-IFRS measures are useful to investors and other users of the Company's financial statements by providing greater transparency into the ongoing operating performance of the Company and its future outlook. Such measures should not be deemed to be an alternative to IFRS requirements.

 

The non-IFRS measures for the reported periods reflect adjustments made to exclude:

Merger and listing expense, which was a one-time and non-cash expense CHF 34.9 million or $38.2 million in the first quarter of 2023 and in the year-to-date total operating expenses.
During the third quarter of 2023, the Company gave effect to the impending dissolution of its Merger Sub 2 entity pursuant to the Business Combination Agreement with EBAC, which is expected to be completed in the coming months. As a result, the cumulative translation adjustments related to Merger Sub 2 previously reported in equity and recognized in other comprehensive loss, were reclassified from equity to the Condensed Consolidated Interim Statement of Loss for the year ended December 31, 2023. The resulting non-cash foreign exchange impact of such reclassification amounted to CHF 5.0 million or $5.7 million for the year ended December 31, 2023.

 

The non-IFRS measures presented here are also unlikely to be comparable with non-IFRS disclosures released by other companies. See the “Reconciliation of Non-IFRS Measures

3

 


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(Unaudited)” table below for a reconciliation of these non-IFRS measures to the most directly comparable IFRS measures.

 

 

Consolidated Statements of Financial Position

 

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4

 


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5

 


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Consolidated Statements of Loss

 

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Reconciliation of Non-IFRS Measures (Unaudited)

 

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-ENDS-

 

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About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS) purposefully driven to save sight and improve eye care. Oculis’ highly differentiated pipeline comprises multiple innovative product candidates in development. It includes OCS-01, a topical eye drop candidate for diabetic macular edema (DME) and for the treatment of inflammation and pain following cataract surgery; OCS-02, a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis; and OCS-05, a disease modifying candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. Headquartered in Switzerland and with operations in the U.S., Oculis’ goal is to deliver life-changing treatments to patients worldwide. The company is led by an experienced management team with a successful track record and is supported by leading international healthcare investors.

 

For more information, please visit: www.oculis.com

 

Oculis Contacts

Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com

 

Investor & Media Relations

LifeSci Advisors

Corey Davis, Ph.D.

cdavis@lifesciadvisors.com

1-212-915-2577

 

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of OCS-01, OCS-02 and OCS-05, including patient impact and market opportunity; the potential of OCS-01 for treating front- and back-of-the-eye diseases; the potential for OCS-01 to become a new standard of care with the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery; the potential of OCS-01 for the treatment of DME, inflammation and pain following ocular surgery and CME; the potential of OCS-02 for treating DED; the potential of OCS-02 to become the first approved topical anti- TNFα for DED; the potential of OCS-05 for treating AON and other neuro-ophthalmic disorders; expected cash runway; expected future milestones and catalysts, including the timing of completing enrolment in the RELIEF trial, topline results for OPTIMIZE-2 and ACUITY trials and IND status for OCS-05; the initiation, timing, progress and results of Oculis’ clinical and preclinical studies; Oculis’ research and development programs, regulatory and business strategy, future development plans, and management; Oculis’ ability to advance product candidates into, and successfully complete, clinical trials; and the timing or likelihood of regulatory filings and approvals, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are

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inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

 

8

 


EX-99.2

Exhibit 99.2

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Oculis Holding AG

Consolidated Financial Statements

 


 

 


Table of Contents

 

 

 

 

 

Report of the Statutory auditor on the 2023 Consolidated Financial Statements

 

Consolidated Statements of Financial Position as of December 31, 2023 and 2022

1

Consolidated Statements of Loss for the years ended December 31, 2023, 2022 and 2021

2

Consolidated Statements of Comprehensive Loss for the years ended December 31, 2023, 2022 and 2021

3

Consolidated Statements of Changes in Equity for the years ended December 31, 2023, 2022 and 2021

4

Consolidated Statements of Cash Flows for the years ended December 31, 2023, 2022 and 2021

5

Notes to the Consolidated Statements

6


 

 

 


 

Oculis Holding AG

Zug

Report of the statutory auditor

to the General Meeting

on the consolidated financial statements 2023

 

 



 

Report of the statutory auditor

to the General Meeting of Oculis Holding AG

Zug

Report on the audit of the consolidated financial statements

Opinion

We have audited the consolidated financial statements of Oculis Holding AG and its subsidiaries (the Group), which comprise the consolidated statement of financial position as of December 31, 2023, and the consolidated statement of loss, the consolidated statement of comprehensive loss, the consolidated statement of changes in equity, the consolidated statement of cash flows for the year then ended, and notes to the consolidated financial statements, including material accounting policy information.

In our opinion, the accompanying consolidated financial statements give a true and fair view of the consolidated financial position of the Group as of December 31, 2023 and its consolidated financial performance and its consolidated cash flows for the year then ended in accordance with IFRS Accounting Standards and comply with Swiss law.

Basis for opinion

We conducted our audit in accordance with Swiss law, International Standards on Auditing (ISAs) and Swiss Standards on Auditing (SA-CH). Our responsibilities under those provisions and standards are further described in the 'Auditor’s responsibilities for the audit of the consolidated financial statements' section of our report. We are independent of the Group in accordance with the provisions of Swiss law and the requirements of the Swiss audit profession, as well as the International Code of Ethics for Professional Accountants (including International Independence Standards) issued by the International Ethics Standards Board for Accountants (IESBA Code), and we have fulfilled our other ethical responsibilities in accordance with these requirements.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.

Our audit approach

Overview

Overall Group materiality: CHF 2,580 thousand

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We concluded full scope audit work at 3 entities, which addressed over 95% of Group’s total operating expenses. In addition, specified procedures were performed on a further 3 entities representing a further 3% of the Group’s total operating expenses.

As key audit matter the following area of focus has been identified:

Accounting Impact of the Capital Reorganization

 

PricewaterhouseCoopers SA, avenue C.-F. Ramuz 45, case postale, 1001 Lausanne, Switzerland

Téléphone: +41 58 792 81 00, www.pwc.ch

PricewaterhouseCoopers SA is a member of the global PricewaterhouseCoopers network of firms, each of which is a separate and independent legal entity.

 



 

Materiality

The scope of our audit was influenced by our application of materiality. Our audit opinion aims to provide reasonable assurance that the consolidated financial statements are free from material misstatement. Misstatements may arise due to fraud or error. They are considered material if, individually or in aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of the consolidated financial statements.

Based on our professional judgement, we determined certain quantitative thresholds for materiality, including the overall Group materiality for the consolidated financial statements as a whole as set out in the table below. These, together with qualitative considerations, helped us to determine the scope of our audit and the nature, timing and extent of our audit procedures and to evaluate the effect of misstatements, both individually and in aggregate, on the consolidated financial statements as a whole.

Overall Group materiality

CHF 2,580 thousand

Benchmark applied

Adjusted loss before tax

Rationale for the materiality benchmark applied

We chose adjusted loss before tax as the benchmark, to be aligned with the common practice in the U.S. for clinical stage life science companies while considering non-recurring items related to the capital reorganization. In addition, in our view, the applied benchmark is aligned with investors and Audit Committee expectations.

We agreed with the Audit Committee that we would report to them misstatements above CHF 258 thousand identified during our audit as well as any misstatements below that amount which, in our view, warranted reporting for qualitative reasons.

Audit scope

We tailored the scope of our audit in order to perform sufficient work to enable us to provide an opinion on the consolidated financial statements as a whole, taking into account the structure of the Group, the accounting processes and controls, and the industry in which the Group operates.

Oculis is a global biopharmaceutical company purposefully driven to save sight and improve eye care. Headquartered in Switzerland, the Group also has operations in the U.S., Iceland, France and Hong-Kong.

The Group’s financial statements are a consolidation of 7 reporting units. We identified 3 reporting units that, in our view, required a full scope audit due to their size or risk characteristics. Specified procedures were also carried out at a further 3 reporting entities to give appropriate coverage of material balances. The majority of the audit procedures was performed by the Group auditor out of Switzerland.

Key audit matters

Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of the consolidated financial statements of the current period. These matters were addressed in the context of our audit of the consolidated financial statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters.

Accounting Impact of the Capital Reorganization

Key audit matter

How our audit addressed the key audit matter

As described in Notes 2, 4, 5, 7C, 13, 15, 16 and 18 to the consolidated financial statements, as of March 2, 2023, a capital reorganization took place within the Group as a result of the merger with European Biotech Acquisition Corp. (“EBAC”), and resulted in the listing of Oculis Holding AG on the NASDAQ. The accounting treatment for the capital reorganization entailed a high degree of complexity including the impact related to the

Addressing the matter involved performing procedures and evaluating audit evidence. These procedures included, among others:

-
obtaining a detailed understanding of the transaction through inquiries with management and review of management’s reorganization

 

3  Oculis Holding AG | Report of the statutory auditor to the General Meeting

 



 

issuance of both ordinary shares to EBAC and Legacy Oculis (formerly Oculis SA) stockholders as well as contingently issuable shares. Despite EBAC being the legal acquirer, Legacy Oculis was determined to be the accounting acquirer for financial reporting purposes. As a result, Oculis incurred merger and listing expense of CHF 34,863 thousand corresponding with charges associated with the capital reorganization, which included non-cash issuance charge representing the difference in the fair value of equity in instruments held by EBAC stockholders over the fair value of identifiable net assets of EBAC. Also, the transaction was accounted for a capital reorganization. Legacy Oculis and EBAC incurred costs directly related to the capital reorganization (“Transaction costs”) of CHF 4,821 thousand associated with equity issuance, which qualify for capitalization and are accounted for as a deduction of share premium. To capture costs associated with the new equity, the Group allocated non-directly attributable capitalizable transaction costs to the various transaction components at the percentages of 38% and 62% for new shares and old shares, respectively.

The principal considerations for our determination that performing procedures relating to the accounting impact of the capital reorganization is a key audit matter are the significant complexities and judgements of the capital reorganization that required a high degree of IFRS technical knowledge. This in turn led to a high degree of audit effort in applying procedures relating to the accounting impact of the capital reorganization to the consolidated financial statements.

 

step-plan and how this was effectuated through the associated accounting entries;
-
tracing the details of the accounting entries to the underlying agreements and cash movements as applicable;
-
we assessed, with the support of financial reporting specialists (i) the accounting treatment under IFRS of the impact of the capital reorganization, (ii) the accounting treatment of the non-cash issuance costs and (iii) the accounting treatment of the capitalizable transaction costs.

On the basis of the procedures performed, we consider that the significant judgements applied and conclusions drawn by management with respect to the Accounting Impact of the Capital Reorganization were reasonable.

Other information

The Board of Directors is responsible for the other information. The other information comprises the information included in the annual report, but does not include the financial statements, the consolidated financial statements, the compensation report and our auditor’s reports thereon.

Our opinion on the consolidated financial statements does not cover the other information and we do not express any form of assurance conclusion thereon.

In connection with our audit of the consolidated financial statements, our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the consolidated financial statements or our knowledge obtained in the audit, or otherwise appears to be materially misstated.

If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report in this regard.

Board of Directors' responsibilities for the consolidated financial statements

The Board of Directors is responsible for the preparation of consolidated financial statements that give a true and fair view in accordance with IFRS Accounting Standards and the provisions of Swiss law, and for such internal control as the Board of Directors determines is necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or error.

In preparing the consolidated financial statements, the Board of Directors is responsible for assessing the Group's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern

 

4  Oculis Holding AG | Report of the statutory auditor to the General Meeting

 



 

basis of accounting unless the Board of Directors either intends to liquidate the Group or to cease operations, or has no realistic alternative but to do so.

Auditor’s responsibilities for the audit of the consolidated financial statements

Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with Swiss law, ISAs and SA-CH will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements.

As part of an audit in accordance with Swiss law, ISAs and SA-CH, we exercise professional judgement and maintain professional scepticism throughout the audit. We also:

Identify and assess the risks of material misstatement of the consolidated financial statements, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinion. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control.
Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Group's internal control.
Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related disclosures made.
Conclude on the appropriateness of the Board of Directors’ use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group's ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in our auditor’s report to the related disclosures in the consolidated financial statements or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based on the audit evidence obtained up to the date of our auditor’s report. However, future events or conditions may cause the Group to cease to continue as a going concern.
Evaluate the overall presentation, structure and content of the consolidated financial statements, including the disclosures, and whether the consolidated financial statements represent the underlying transactions and events in a manner that achieves fair presentation.
Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express an opinion on the consolidated financial statements. We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our audit opinion.

We communicate with the Board of Directors or its relevant committee regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit.

We also provide the Board of Directors or its relevant committee with a statement that we have complied with relevant ethical requirements regarding independence, and communicate with them regarding all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, actions taken to eliminate threats or safeguards applied.

From the matters communicated with the Board of Directors or its relevant committee, we determine those matters that were of most significance in the audit of the consolidated financial statements of the current period and are therefore the key audit matters. We describe these matters in our auditor’s report unless law or regulation precludes public disclosure about the matter or when, in extremely rare circumstances, we determine that a matter should not be communicated in our report because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication.

 

5  Oculis Holding AG | Report of the statutory auditor to the General Meeting

 



 

Report on other legal and regulatory requirements

In accordance with article 728a para. 1 item 3 CO and PS-CH 890, we confirm the existence of an internal control system that has been designed, pursuant to the instructions of the Board of Directors, for the preparation of the consolidated financial statements.

We recommend that the consolidated financial statements submitted to you be approved.

PricewaterhouseCoopers SA

/s/ Michael Foley

/s/ Alex Fuhrer

Licensed audit expert

Auditor in charge

Licensed audit expert

Lausanne, March 19, 2024

 

6  Oculis Holding AG | Report of the statutory auditor to the General Meeting

 


 

Oculis Holding AG, Zug

Consolidated Statements of Financial Position

(in CHF thousands)

 

 

 

 

 

As of December 31,

 

 

As of December 31,

 

 

 

Note

 

2023

 

 

2022

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-current assets

 

 

 

 

 

 

 

 

Property and equipment, net

 

8

 

 

288

 

 

 

365

 

Intangible assets

 

9

 

 

12,206

 

 

 

12,206

 

Right-of-use assets

 

10

 

 

755

 

 

 

758

 

Other non-current assets

 

 

 

 

89

 

 

 

74

 

Total non-current assets

 

 

 

 

13,338

 

 

 

13,403

 

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Other current assets

 

11

 

 

8,488

 

 

 

2,959

 

Accrued income

 

11

 

 

876

 

 

 

912

 

Short-term financial assets

 

14

 

 

53,324

 

 

 

-

 

Cash and cash equivalents

 

14

 

 

38,327

 

 

 

19,786

 

Total current assets

 

 

 

 

101,015

 

 

 

23,657

 

 

 

 

 

 

 

 

 

 

TOTAL ASSETS

 

 

 

 

114,353

 

 

 

37,060

 

 

 

 

 

 

 

 

 

 

EQUITY AND LIABILITIES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shareholders' equity

 

 

 

 

 

 

 

 

Share capital

 

16

 

 

366

 

 

 

39

 

Share premium

 

16

 

 

288,162

 

 

 

10,742

 

Reserve for share-based payment

 

13

 

 

6,379

 

 

 

2,771

 

Actuarial loss on post-employment benefit obligations

 

12

 

 

(1,072

)

 

 

(264

)

Treasury shares

 

16

 

 

-

 

 

 

(1

)

Cumulative translation adjustments

 

 

 

 

(327

)

 

 

(300

)

Accumulated losses

 

 

 

 

(199,780

)

 

 

(110,978

)

Total equity

 

 

 

 

93,728

 

 

 

(97,991

)

 

 

 

 

 

 

 

 

 

Non-current liabilities

 

 

 

 

 

 

 

 

Long-term lease liabilities

 

10

 

 

431

 

 

 

491

 

Long-term financial debt

 

15

 

 

-

 

 

 

122,449

 

Long-term payables

 

 

 

 

378

 

 

 

-

 

Defined benefit pension liabilities

 

12

 

 

728

 

 

 

91

 

Total non-current liabilities

 

 

 

 

1,537

 

 

 

123,031

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Trade payables

 

 

 

 

7,596

 

 

 

3,867

 

Accrued expenses and other payables

 

17

 

 

5,948

 

 

 

8,011

 

Short-term lease liabilities

 

10

 

 

174

 

 

 

142

 

Warrant liabilities

 

18

 

 

5,370

 

 

 

-

 

Total current liabilities

 

 

 

 

19,088

 

 

 

12,020

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

 

 

 

20,625

 

 

 

135,051

 

 

 

 

 

 

 

 

 

 

TOTAL EQUITY AND LIABILITIES

 

 

 

 

114,353

 

 

 

37,060

 

 

The accompanying notes form an integral part of the consolidated financial statements.

1


 

Oculis Holding AG, Zug

Consolidated Statements of Loss

(in CHF thousands, except loss per share data)

 

 

 

 

 

For the years ended December 31,

 

 

 

Note

 

2023

 

 

2022

 

 

2021

 

Grant income

 

7. (A) / 11

 

 

883

 

 

 

912

 

 

 

960

 

Operating income

 

 

 

 

883

 

 

 

912

 

 

 

960

 

Research and development expenses

 

7. (B)

 

 

(29,247

)

 

 

(22,224

)

 

 

(9,568

)

General and administrative expenses

 

7. (B)

 

 

(17,487

)

 

 

(11,064

)

 

 

(4,624

)

Merger and listing expense

 

7. (B)

 

 

(34,863

)

 

 

-

 

 

 

-

 

Operating expenses

 

 

 

 

(81,597

)

 

 

(33,288

)

 

 

(14,192

)

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

 

 

(80,714

)

 

 

(32,376

)

 

 

(13,232

)

 

 

 

 

 

 

 

 

 

 

 

 

Finance income

 

7. (C)

 

 

1,429

 

 

 

126

 

 

 

21

 

Finance expense

 

7. (C)

 

 

(1,315

)

 

 

(6,442

)

 

 

(5,120

)

Fair value adjustment on warrant liabilities

 

7. (C) / 18

 

 

(3,431

)

 

 

-

 

 

 

-

 

Foreign currency exchange (loss) gain

 

7. (C)

 

 

(4,664

)

 

 

49

 

 

 

(193

)

Finance result

 

 

 

 

(7,981

)

 

 

(6,267

)

 

 

(5,292

)

 

 

 

 

 

 

 

 

 

 

 

 

Loss before tax for the period

 

 

 

 

(88,695

)

 

 

(38,643

)

 

 

(18,524

)

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

7. (D)

 

 

(107

)

 

 

(55

)

 

 

(27

)

 

 

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

 

 

 

(88,802

)

 

 

(38,698

)

 

 

(18,552

)

 

 

 

 

 

 

 

 

 

 

 

 

Loss per share:

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted loss attributable to equity holders

 

22

 

 

(2.97

)

 

 

(11.32

)

 

 

(5.84

)

 

The accompanying notes form an integral part of the consolidated financial statements.

2


 

Oculis Holding AG, Zug

Consolidated Statements of Comprehensive Loss

(in CHF thousands)

 

 

 

 

 

For the years ended December 31,

 

 

Note

 

 

2023

 

 

2022

 

 

2021

 

Loss for the period

 

 

 

 

(88,802

)

 

 

(38,698

)

 

 

(18,552

)

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Items that will not be reclassified to profit or loss:

 

 

 

 

 

 

 

 

 

 

 

Actuarial gains/(losses) of defined benefit plans

12

 

 

 

(808

)

 

 

744

 

 

 

88

 

Items that may be reclassified subsequently to profit or loss:

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation differences

2. (D)

 

 

 

(5,005

)

 

 

3

 

 

 

(28

)

Foreign currency translation differences recycling

5

 

 

 

4,978

 

 

 

-

 

 

 

-

 

Other comprehensive profit/(loss) for the period

 

 

 

 

(835

)

 

 

747

 

 

 

60

 

 

 

 

 

 

 

 

 

 

 

 

 

Total comprehensive loss for the period

 

 

 

 

(89,637

)

 

 

(37,951

)

 

 

(18,492

)

 

The accompanying notes form an integral part of the consolidated financial statements.

3


 

Oculis Holding AG, Zug

Consolidated Statements of Changes in Equity

(in CHF thousands, except share numbers)

 

 

Legacy Oculis share capital

 

Legacy Oculis treasury shares

 

 

Oculis share capital

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Note

 

Shares

 

Share capital

 

Shares

 

Treasury shares

 

 

Shares

 

Share capital

 

Share premium

 

Reserve for share-based payment

 

Cumulative translation adjustment

 

Actuarial loss on post-employment benefit obligations

 

Accumulated losses

 

Total

Balance as of December 31, 2020 (as previously reported)

 

 

 

2,967,155

 

297

 

(100,000)

 

(100)

 

 

-

 

-

 

9,609

 

1,640

 

(275)

 

(1,096)

 

(53,728)

 

(43,654)

Retroactive application of the recapitalization due to the business combination

 

5 / 2 (B) / 16

 

424,985

 

(263)

 

(14,323)

 

99

 

 

-

 

-

 

164

 

-

 

-

 

-

 

-

 

-

Balance as of January 1, (effect of the recapitalization)

 

 

 

3,392,140

 

34

 

(114,323)

 

(1)

 

 

-

 

-

 

9,773

 

1,640

 

(275)

 

(1,096)

 

(53,728)

 

(43,654)

Loss for the period

 

 

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

-

 

-

 

(18,552)

 

(18,552)

Other comprehensive profit/(loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Actuarial gain on post-employment benefit obligations

 

4. (C) / 12

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

-

 

88

 

-

 

88

Foreign currency translation differences

 

2. (D)

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

(28)

 

-

 

-

 

(28)

Total comprehensive loss for the period

 

 

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

(28)

 

88

 

(18,552)

 

(18,492)

Share-based compensation expense

 

13

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

328

 

-

 

-

 

-

 

328

Restricted shares awards

 

 

 

441,419

 

4

 

-

 

-

 

 

-

 

-

 

872

 

-

 

-

 

-

 

-

 

876

Transaction costs

 

 

 

-

 

-

 

-

 

-

 

 

-

 

-

 

(12)

 

-

 

-

 

-

 

-

 

(12)

Balance as of December 31, 2021 (effect of the recapitalization)

 

 

 

3,833,559

 

38

 

(114,323)

 

(1)

 

 

-

 

-

 

10,632

 

1,967

 

(303)

 

(1,008)

 

(72,280)

 

(60,955)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2021 (as previously reported)

 

 

 

3,353,271

 

335

 

(100,000)

 

(100)

 

 

-

 

-

 

10,434

 

1,967

 

(303)

 

(1,008)

 

(72,280)

 

(60,955)

Retroactive application of the recapitalization due to the business combination

 

5 / 2 (B) / 16

 

480,288

 

(297)

 

(14,323)

 

99

 

 

-

 

-

 

198

 

-

 

-

 

-

 

-

 

-

Balance as of January 1, 2022 (effect of the recapitalization)

 

 

 

3,833,559

 

38

 

(114,323)

 

(1)

 

 

-

 

-

 

10,632

 

1,967

 

(303)

 

(1,008)

 

(72,280)

 

(60,955)

Loss for the period

 

 

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

-

 

-

 

(38,698)

 

(38,698)

Other comprehensive profit/(loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Actuarial gain on post-employment benefit obligations

 

4. (C) / 12

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

-

 

744

 

-

 

744

Foreign currency translation differences

 

2. (D)

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

3

 

-

 

-

 

3

Total comprehensive loss for the period

 

 

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

3

 

744

 

(38,698)

 

(37,951)

Share-based compensation expense

 

13

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

804

 

-

 

-

 

-

 

804

Transaction costs

 

 

 

-

 

-

 

-

 

-

 

 

-

 

-

 

(9)

 

-

 

-

 

-

 

-

 

(9)

Stock option exercised

 

13

 

61,163

 

1

 

-

 

-

 

 

-

 

-

 

119

 

-

 

-

 

-

 

-

 

120

Balance as of December 31, 2022 (effect of the recapitalization)

 

 

 

3,894,722

 

39

 

(114,323)

 

(1)

 

 

-

 

-

 

10,742

 

2,771

 

(300)

 

(264)

 

(110,978)

 

(97,991)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2022 (as previously reported)

 

 

 

3,406,771

 

340

 

(100,000)

 

(100)

 

 

-

 

-

 

10,540

 

2,771

 

(300)

 

(264)

 

(110,978)

 

(97,991)

Retroactive application of the recapitalization due to the business combination

 

5 / 2 (B) / 16

 

487,951

 

(301)

 

(14,323)

 

99

 

 

-

 

-

 

202

 

-

 

-

 

-

 

-

 

-

Balance as of January 1, 2023 (effect of the recapitalization)

 

 

 

3,894,722

 

39

 

(114,323)

 

(1)

 

 

-

 

-

 

10,742

 

2,771

 

(300)

 

(264)

 

(110,978)

 

(97,991)

Loss for the period

 

 

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

-

 

-

 

(88,802)

 

(88,802)

Other comprehensive profit/(loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Actuarial loss on post-employment benefit obligations

 

4. (C) / 12

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

-

 

(808)

 

-

 

(808)

Foreign currency translation differences

 

2. (D)

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

(5,005)

 

-

 

-

 

(5,005)

Foreign currency translation differences recycling

 

5

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

4,978

 

-

 

-

 

4,978

Total comprehensive loss for the period

 

 

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

(27)

 

(808)

 

(88,802)

 

(89,637)

Share-based compensation expense

 

13

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

3,608

 

-

 

-

 

-

 

3,608

Conversion of Legacy Oculis ordinary shares and treasury shares into Oculis ordinary shares

 

5 / 16

 

(3,894,722)

 

(39)

 

114,323

 

1

 

 

3,780,399

 

38

 

-

 

-

 

-

 

-

 

-

 

-

Conversion of Legacy Oculis long-term financial debt into Oculis ordinary shares

 

5 / 15 / 16

 

-

 

-

 

-

 

-

 

 

16,496,603

 

165

 

124,637

 

-

 

-

 

-

 

-

 

124,802

Issuance of ordinary shares to PIPE investors

 

5 / 16

 

-

 

-

 

-

 

-

 

 

7,118,891

 

71

 

66,983

 

-

 

-

 

-

 

-

 

67,054

Issuance of ordinary shares under CLA

 

5 / 16

 

-

 

-

 

-

 

-

 

 

1,967,000

 

20

 

18,348

 

-

 

-

 

-

 

-

 

18,368

Issuance of ordinary shares to EBAC shareholders

 

5 / 16

 

-

 

-

 

-

 

-

 

 

3,370,480

 

33

 

35,492

 

-

 

-

 

-

 

-

 

35,525

Transaction costs related to the business combination

 

5 / 16

 

-

 

-

 

-

 

-

 

 

-

 

-

 

(4,821)

 

-

 

-

 

-

 

-

 

(4,821)

Proceeds from sale of shares in public offering

 

5 / 16

 

-

 

-

 

-

 

-

 

 

3,654,234

 

36

 

38,143

 

-

 

-

 

-

 

-

 

38,179

Transaction costs related to the public offering

 

5 / 16

 

-

 

-

 

-

 

-

 

 

-

 

-

 

(3,361)

 

-

 

-

 

-

 

-

 

(3,361)

Stock option exercised

 

13 / 16

 

-

 

-

 

-

 

-

 

 

112,942

 

1

 

273

 

-

 

-

 

-

 

-

 

274

Issuance of shares in connection with warrant exercises

 

16 / 18

 

-

 

-

 

-

 

-

 

 

149,156

 

2

 

1,726

 

-

 

-

 

-

 

-

 

1,728

Balance as of December 31, 2023

 

 

 

-

 

-

 

-

 

-

 

 

36,649,705

 

366

 

288,162

 

6,379

 

(327)

 

(1,072)

 

(199,780)

 

93,728

 

The accompanying notes form an integral part of the consolidated financial statements.

4


 

Oculis Holding AG, Zug

Consolidated Statements of Cash Flows

(in CHF thousands)

 

 

 

 

For the years ended December 31,

 

 

 

Note

 

2023

 

 

2022

 

 

2021

 

Operating activities

 

 

 

 

 

 

 

 

 

 

 

Loss before tax for the period

 

 

 

 

(88,695

)

 

 

(38,643

)

 

 

(18,524

)

 

 

 

 

 

 

 

 

 

 

 

 

Non-cash adjustments:

 

 

 

 

 

 

 

 

 

 

 

- Financial result

 

 

 

 

3,454

 

 

 

(500

)

 

 

53

 

- Depreciation of property and equipment

 

8

 

 

125

 

 

 

132

 

 

 

88

 

- Depreciation of right-of-use assets

 

10

 

 

162

 

 

 

167

 

 

 

147

 

- Share-based compensation expense

 

13

 

 

3,608

 

 

 

804

 

 

 

328

 

- Payroll expenses related to restricted stock

 

13 / 16

 

 

-

 

 

 

-

 

 

 

876

 

- Interest expense on Series B and C preferred shares

 

15 / 7.(C)

 

 

1,266

 

 

 

6,343

 

 

 

4,996

 

- Interest on lease liabilities

 

10

 

 

42

 

 

 

45

 

 

 

49

 

- Post-employment benefits

 

12

 

 

(171

)

 

 

(9

)

 

 

(139

)

- Non-realized foreign exchange differences

 

15 / 7.(C)

 

 

(30

)

 

 

583

 

 

 

(792

)

- Fair value adjustment on warrant liabilities

 

18

 

 

3,431

 

 

 

-

 

 

 

-

 

- Merger and listing expense

 

5

 

 

34,863

 

 

 

-

 

 

 

-

 

Working capital adjustments:

 

 

 

 

 

 

 

 

 

 

 

- De/(Increase) in other current assets

 

11

 

 

(5,556

)

 

 

(1,796

)

 

 

(731

)

- De/(Increase) in accrued income

 

11

 

 

36

 

 

 

(152

)

 

 

233

 

- Changes in receivables/payables from/to related parties

 

 

 

 

-

 

 

 

-

 

 

 

29

 

- (De)/Increase in trade payables

 

 

 

 

3,729

 

 

 

3,043

 

 

 

30

 

- (De)/Increase in accrued expenses and other payables

 

17

 

 

(11,549

)

 

 

4,903

 

 

 

(352

)

- (De)/Increase in other operating assets/liabilities

 

 

 

 

(29

)

 

 

-

 

 

 

-

 

- (De)/Increase in long-term payables

 

 

 

 

378

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest received

 

 

 

 

1,238

 

 

 

126

 

 

 

-

 

Interest paid on lease liabilities

 

 

 

 

(46

)

 

 

(100

)

 

 

(116

)

Taxes paid

 

 

 

 

(101

)

 

 

(20

)

 

 

-

 

Net cash outflow from operating activities

 

 

 

 

(53,845

)

 

 

(25,074

)

 

 

(13,825

)

 

 

 

 

 

 

 

 

 

 

 

 

Investing activities

 

 

 

 

 

 

 

 

 

 

 

Payment for purchase of property and equipment, net

 

8

 

 

(48

)

 

 

(65

)

 

 

(28

)

Payment for short-term financial assets, net

 

14

 

 

(54,163

)

 

 

-

 

 

 

-

 

Payment for purchase of intangible assets

 

9

 

 

-

 

 

 

(3,483

)

 

 

-

 

Net cash outflow from investing activities

 

 

 

 

(54,211

)

 

 

(3,548

)

 

 

(28

)

 

 

 

 

 

 

 

 

 

 

 

 

Financing activities

 

 

 

 

 

 

 

 

 

 

 

Proceeds from the shares issued to PIPE investors

 

5

 

 

67,054

 

 

 

-

 

 

 

-

 

Proceeds from the shares issued to CLA investors

 

5

 

 

18,368

 

 

 

-

 

 

 

-

 

Proceeds from EBAC non-redeemed shareholders

 

5

 

 

12,014

 

 

 

-

 

 

 

-

 

Transaction costs related to the business combination

 

5

 

 

(4,607

)

 

 

(214

)

 

 

-

 

Proceeds from sale of shares in public offering

 

5

 

 

38,179

 

 

 

-

 

 

 

-

 

Transactions costs related to equity issuance in public offering

 

5

 

 

(2,983

)

 

 

-

 

 

 

-

 

Proceeds from exercises of warrants

 

18

 

 

1,531

 

 

 

-

 

 

 

-

 

Proceeds from stock options exercised

 

13 / 16

 

 

274

 

 

 

120

 

 

 

-

 

Proceeds from issuance of preferred shares, classified as liabilities

 

15

 

 

-

 

 

 

2,030

 

 

 

56,096

 

Transaction costs for issuance of preferred shares, classified as liabilities/capital increase

 

 

 

 

-

 

 

 

(63

)

 

 

(804

)

Principal payment of lease obligations

 

10

 

 

(158

)

 

 

(159

)

 

 

(98

)

Net cash inflow from financing activities

 

 

 

 

129,672

 

 

 

1,714

 

 

 

55,194

 

 

 

 

 

 

 

 

 

 

 

 

 

Increase/(Decrease) in cash and cash equivalents

 

 

 

 

21,616

 

 

 

(26,909

)

 

 

41,341

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents, beginning of period

 

14

 

 

19,786

 

 

 

46,277

 

 

 

4,952

 

Effect of foreign exchange rate changes

 

 

 

 

(3,075

)

 

 

418

 

 

 

(16

)

Cash and cash equivalents, end of period

 

14

 

 

38,327

 

 

 

19,786

 

 

 

46,277

 

 

 

 

 

 

 

 

 

 

 

 

 

Net cash and cash equivalents variation

 

 

 

 

21,616

 

 

 

(26,909

)

 

 

41,341

 

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental Non-Cash Financing Information

 

 

 

 

 

 

 

 

 

 

 

Transaction costs recorded in accrued expenses and other payables/trade payables

 

 

 

 

378

 

 

 

356

 

 

 

-

 

 

The accompanying notes form an integral part of the consolidated financial statements.

5


 

Oculis Holding AG, Zug

Notes to the consolidated financial statements

 

1.
CORPORATE INFORMATION

 

Oculis Holding AG ("Oculis" or "the Company") 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.

 

The Company controls 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 is pending dissolution which will be completed in April 2024. The Company and its wholly-owned subsidiaries form the Oculis Group (the "Group"). Prior to the Business Combination (as defined in Note 5), Oculis SA ("Legacy Oculis"), which was incorporated in Lausanne, Switzerland on December 11, 2017, and its wholly-owned subsidiaries Oculis Iceland, Oculis France, Oculis U.S. 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 pharmaceutical 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.

 

The consolidated financial statements of Oculis as of and for the year ended December 31, 2023, were approved and authorized for issue by the Company's Board of Directors on March 15, 2024.

 

 

2.
BASIS OF PREPARATION
(A)
Going concern

The Group's accounts are prepared on a going concern basis. To date, the Group has financed its cash requirements primarily from share issuances, as well as government research and development grants. The recent business combination with European Biotech Acquisition Corp. (“EBAC”) and the listing in NASDAQ early in March 2023 raised additional funding to secure business continuity as explained under note 5. The Board of Directors believes that 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 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. To date, the Company has financed its cash requirements primarily through the sale of its preferred stock, proceeds from the Business Combination, PIPE Financing and conversion of CLA and the sale of its common stock. 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.

(B)
Statement of compliance

The consolidated financial statements of Oculis are prepared in accordance with IFRS Accounting Standards ("IFRS") as issued by the International Accounting Standards Board (“IASB”).

 

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 5, 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

6


 

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.

 

Reclassifications: given the immateriality of amounts recorded in financial assets and deferred income tax assets as of December 31, 2023 and 2022, these line items have been aggregated into Other non-current assets in the Consolidated Statements of Financial Position presented herein.

(C)
Basis of measurement

The policies set out below are consistently applied to all the years presented. The consolidated financial statements have been prepared under the historical cost convention, unless stated otherwise in the accounting policies in Note 3.