Correspondence 0001193125-22-302900 from Oculis Holding AG (OCS, OCSAW) (CIK 0001953530) (OCS)
Oculis Holding AG (OCS, OCSAW) (CIK 0001953530)
Date: Dec. 12, 2022 · CIK: 0001953530 · Accession: 0001193125-22-302900
AI Filing Summary & Sentiment
File numbers found in text: 333-268201
Referenced dates: December 2, 2022
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CORRESP
Derek Dostal
+1 212 450 4322
derek.dostal@davispolk.com
Davis Polk & Wardwell LLP
450 Lexington Avenue
New York, NY 10017
davispolk.com
December 12, 2022
Re:
Oculis Holding AG
Registration Statement on Form F-4
Filed November 7, 2022
File No. 333-268201
U.S. Securities and Exchange Commission
Division of Corporation
Finance
Office of Trade & Services
100 F Street,
N.E.
Washington, D.C. 20549
Attn:
Li Xiao
Daniel Gordon
Daniel Crawford
Ada D. Sarmento
Ladies and Gentlemen:
On behalf of our client, Oculis Holding
AG, (the “Company”), this letter sets forth the Company’s responses to the comments provided by the staff (the “Staff”) of the Division of Corporation Finance of the U.S. Securities and Exchange Commission
relating to the Company’s Registration Statement on Form F-4 (the “Registration Statement”) contained in the Staff’s letter dated December 2, 2022 (the “Comment
Letter”). In response to the comments set forth in the Comment Letter, the Company has revised the Registration Statement and is filing Amendment No. 1 to the Registration Statement on
Form F-4 (“Amendment No. 1”) together with this response letter. Amendment No. 1 also contains certain additional updates and revisions.
For the convenience of the Staff, each comment from the Comment Letter is restated in italics prior to the response to such comment. All references to
page numbers and captions (other than those in the Staff’s comments) correspond to pages and captions in Amendment No. 1.
Registration Statement on Form F-4 Filed November 7, 2022
What equity stake will the current holders of public shares of EBAC . . . , page 18
1.
Please disclose the sponsor and its affiliates’ total potential ownership interest in the combined
company, assuming exercise and conversion of all securities.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 18 and 19 of Amendment No. 1.
Risk Factors, page 59
2.
Please highlight the risk that the sponsor will benefit from the completion of a business combination and
may be incentivized to complete an acquisition of a less favorable target company or on terms less favorable to shareholders rather than liquidate.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 47, 137 and 370 of Amendment No. 1.
Unaudited Pro Forma Condensed Combined Financial Information, page 176
3.
Revise your disclosure to show the potential impact of redemptions on the per share value of the shares
owned by non-redeeming shareholders by including a sensitivity analysis showing a range of redemption scenarios, including minimum, maximum and interim redemption levels.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 18-20 of Amendment No. 1 to show a range of redemption scenarios and the potential impact of redemptions on the per share value of the
shares owned by the non-redeeming shareholders.
Unaudited Pro Forma Condensed Combined Financial Information, page 176
4.
Please revise to disclose all possible sources and extent of dilution that shareholders who elect not to
redeem their shares may experience in connection with the business combination. Provide disclosure of the impact of each significant source of dilution, including the amount of equity held by founders, convertible securities, including warrants
retained by redeeming shareholders, at each of the redemption levels detailed in your sensitivity analysis, including any needed assumptions.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 18-20 in the same table used for the response to Comment 3 to disclose all possible sources and extent of dilution that shareholders who elect
not to redeem their shares may experience in connection with the Business Combination.
Unaudited Pro Forma Condensed Combined Financial Information, page 176
5.
It appears that underwriting fees remain constant and are not adjusted based on redemptions. Revise your
disclosure to disclose the effective underwriting fee on a percentage basis for shares at each redemption level presented in your sensitivity analysis related to dilution.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 18-20 in the same table used for the response to Comment 3 to disclose the effective underwriting fee on a percentage basis for shares at each
redemption level.
Unaudited Pro forma Condensed Combined Statement of Financial Position as of June 30, 2022, page 181
6.
With respect to the 4,251,595 Public Warrants and 151,699 Private Warrants issued by EBAC in connection with
its IPO, please tell us whether you anticipate any change in classification between liabilities and equity upon consummation of the business combination. If so, please revise your pro forma financial statements accordingly.
Response:
The Company respectfully advises the Staff that it does not expect any change in classification of 4,251,595 Public Warrants and 151,699 Private Warrants between liabilities and equity upon consummation of the business
combination and that the warrants will continue to be classified as liabilities. The Company has revised the disclosure on page 182 in response to the Staff’s comment.
Unaudited Pro forma Condensed Combined Statement of Operations for the Year Ended December 31, 2021, page 184
7.
In Note 4 related party transaction of EBAC financial statement at page
F-15, you disclosed EBAC founder shares are subject to share based compensation accounting upon occurrence of a business combination as a performance condition under ASC 718. Please tell us whether you
anticipate such accounting under IFRS as issued by the IASB. If so, please revise your pro forma financial statements accordingly.
Response:
The Company respectfully advises the Staff that while the EBAC founder shares could be compensatory and therefore within the scope of IFRS 2, the Company did not specifically address the accounting as the Company believes the
resulting accounting would not have an impact on the pro forma financial information. Two factors were considered by the Company in making this determination. The Company respectfully notes that the Business Combination is depicted as a capital
reorganization (with a contemporaneous listing), or capital raise, rather than a business combination in accordance with IFRS 3; accordingly, the Company concluded that including a pro forma
adjustment
to reflect a potential charge pursuant to IFRS 2 for the executives of the acquired entity, while consistent with pro forma treatment that would be accorded a business combination between two operating companies, is inconsistent
with the transaction accounting under IFRS for a capital raising transaction (which would generally not be expected to generate any impact under IFRS other than the balance sheet recognition of proceeds to the issuer, net of the related costs).
Additionally, the Company respectfully considered that the EBAC founder shares are also inherently reflected in the derivation of (and are arguably the primary driver of) the listing charge calculated in accordance with IFRS 2 upon consummation of
the Business Combination. Accordingly, the Company also believes that recognition of a charge pursuant to IFRS 2 for the initial issuance/transfer of those shares pursuant to IFRS 2 would effectively recognize the same economic transfer or sacrifice
twice in the pro forma income statement for the year ended December 31, 2021, which the Company concluded would neither be appropriate nor accretive to investors’ decision-making processes.
Business of Oculis and Certain Information about Oculis, page 193
8.
We note several statements that if your product candidates were approved today, they would be the first and
only such treatment for certain indications. These statements are speculative and are inappropriate given the length of time and uncertainty with respect to securing marketing approval. If your intention is to convey your belief that your product
candidates utilize a novel technology or approach, you may discuss how your technology differs from technology used by competitors or that you are not aware of competing products that are further along in the development process. Statements such as
these should be accompanied by cautionary language that the statements are not intended to give any indication that your product candidates have been proven effective or will receive regulatory approval.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 198, 202, 203 and 204 of Amendment No. 1.
Company Overview, page 193
9.
Please revise where appropriate to provide the data and assumptions relied on for your estimated indication
populations and estimated addressable market of your product candidates for each indication.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 198 and 199 of Amendment No. 1.
Company Overview, page 193
10.
We note the inclusion of the glaucoma, geographic atrophy, diabetic retinopathy, and neurotrophic keratitis
indications for OCS-05, and the OCS-03 and OCS-04 programs in your pipeline table on page 193. Please explain why each program is
sufficiently material to your business to warrant inclusion in your pipeline table and revise to provide additional disclosure about these programs in your Business of Oculis and Certain Information about Oculis section including, without
limitation, the current status of program development and future development plans. Alternatively, remove the programs from your pipeline table.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 217 and 218 of Amendment No. 1.
Company Overview, page 193
11.
Given the early stage and lack of disclosure regarding the undisclosed product candidate, please remove the
undisclosed product candidate row from the pipeline table.
Response:
The Company acknowledges the Staff’s comment and has revised the pipeline table on page 197 of Amendment No. 1.
Company Overview, page 193
12.
Please revise your statements on pages 194 and 204 that topical ocular administration of OCS-02 showed efficacy as efficacy determinations are solely within the authority of the FDA or similar regulatory body. You may provide a summary of the objective data from your trials without including conclusions
related to efficacy. Similarly, please revise the statement on page 196 that you are conducting a Phase 3 clinical trial of OCS-01 to “confirm its efficacy” in treating inflammation and pain
following ocular surgery and remove the reference to “positive” Phase 2 clinical trial results achieved with OCS-01 in treating DME on page 201.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 199, 201, 206 and 209 of Amendment No. 1.
Company Overview, page 193
13.
We note your disclosure on page 82 that OCS-05 has been subject to a
clinical hold by the FDA since 2016. Please revise your discussion of OCS-05 on pages 193, 195 and 208, and your pipeline table to discuss the clinical hold and the steps that you must take to clear the hold.
Please also include in your discussion the fact that if you are unable to clear the clinical hold, OCS-05 may not receive clearance from the FDA to proceed with human clinical trials, may never receive
regulatory approval from the FDA, and you may be unable to market and commercialize OCS-05 in the United States.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 52, 85, 197, 200 and 214 of Amendment No. 1.
Our Executive Management Team, page 195
14.
Please limit the disclosure of specific investors to those identified in the Principal Shareholder table on
page 320. Additionally, indicate that prospective investors should not rely on the named investors’ investment decision, that these investors may have different risk tolerances and that the investors acquired their shares at a significant
discount to the market price, if true.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on page 200 of Amendment No. 1.
Our clinical development candidates, page 197
15.
Please revise to disclose the jurisdiction of your DIAMOND trial.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on page 203 of Amendment No. 1.
Our clinical development candidates, page 197
16.
Please revise page 199 to provide the basis for your belief that approximately 40% of patients have a
suboptimal response to therapy after 12 weeks of anti-VEGF treatment.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on page 204 of Amendment No. 1.
Material Licenses, Partnerships and Collaborations, page 211
17.
Please revise your disclosure of the tiered royalties percentage for both license agreements to further
define a “low double-digit percentage” to a range within 10% percentage points of mid-single digit. Please also revise the disclosure of the royalty term for both agreements to specify the number of
years following the first commercial sale that royalties are payable.
Response:
The Company acknowledges the Staff’s comment and has revised the disclosure on pages 218, 219, 257 and 258 of Amendment No. 1.
Oculis Management’s Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations – Research and Development Expenses, page 242
18.
Please revise to further disclose the costs incurred on each of your key research and development projects.
If you do not track your research and development costs by project, please disclose that fact and explain why you do not maintain and evaluate research and development costs by project.
Response:
The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 245 and 246 of Amendment No. 1
stating that it does not track research and development costs by project.
The
Company respectfully advises the Staff that the Company has, since inception, pursued a number of early-stage research and development projects that, at any given time, involve employees, manufacturing, infrastructure and other internal resources
that are not directly tied to a specific product candidate, until such product candidate reaches the clinical trial stage. The Company has historically tracked its research and development costs under its various programs on an aggregate basis and
not on a project-by-project basis. Its considerations for doing so are as follows:
• the Company is a clinical-stage company and recently progressed to have multiple product
candidates in late-stage clinical trials.
• the Company uses cash flow as the primary measure to manage its business and the Company’s
management historically has received and reviewed its results of operations as a whole and not on a project-by-project basis when making decisions about allocating
resources and assessing performance of the Company’s ability to operate; and
• for accounting purposes, the Company reports its development programs on an aggregate
basis.
Background of the Business Combination, page 349
19.
Please revise to provide additional detail of how EBAC eliminated the six potential targets other than
Oculis from consideration. For example, without limitation, disclose who initiated discussions with each target, describe the negotiations, including when they started and ended, the reasons negotiations ceased, and describe each target’s
business.
Response:
The Company acknow