Clearside Biomedical, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Clearside Biomedical, Inc. filed its 2023 10-K, detailing various licensing, sales agreements, and equity transactions.</b>

AI Summary

Clearside Biomedical, Inc. (CLSDQ) filed a Annual Report (10-K) with the SEC on March 12, 2024. Clearside Biomedical, Inc. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing details various agreements including license arrangements with Arctic Vision Limited and Biocryst Pharmaceuticals Inc. It also mentions At-The-Market (ATM) sales agreements with Cantor Fitzgerald & Co.1 and Cowen and Company, LLC. The report covers equity transactions such as employee stock options, restricted stock units, and common stock warrants. Key dates include the fiscal year end of December 31, 2023, and filing date of March 12, 2024.

Why It Matters

For investors and stakeholders tracking Clearside Biomedical, Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of Clearside's financial health, operational activities, and strategic partnerships for the fiscal year 2023. Investors and stakeholders can use this report to assess the company's performance, understand its contractual obligations, and evaluate future growth prospects.

Risk Assessment

Risk Level: medium — Clearside Biomedical, Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, lengthy development cycles, and substantial R&D investment, as indicated by the mention of R&D expenses and various licensing agreements.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to understand Clearside's current financial position and potential future challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (The period covered by the 10-K filing.)
• 2024-03-12 — Filing Date (Date the 10-K was submitted to the SEC.)

Key Players & Entities

• Clearside Biomedical, Inc. (company) — Filer of the 10-K report.
• Arctic Vision Limited (company) — Party to a license arrangement with Clearside.
• Biocryst Pharmaceuticals Inc. (company) — Mentioned in relation to a license arrangement.
• Cantor Fitzgerald & Co.1 (company) — Underwriter for an At-The-Market sales agreement.
• Cowen and Company, LLC (company) — Underwriter for an At-The-Market sales agreement.
• 2023-12-31 (date) — Fiscal year end date.
• 2024-03-12 (date) — Filing date of the 10-K.

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by government authorities, which can impact product development, approval, manufacturing, and marketing.
• Research and Development Expenses [high — financial]: Significant investment in research and development is required, with associated risks of failure and uncertain commercial success.
• Competition [medium — market]: The company faces competition from other pharmaceutical and biotechnology companies, which could affect market share and profitability.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-12: 10-K Filing Date — Date the annual report was officially submitted.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (Provides a detailed overview of the company's financial health and operations for the fiscal year.)

At-The-Market Sales Agreement

An agreement allowing a company to sell shares of its stock over time at prevailing market prices. (Indicates potential for equity financing and dilution.)

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share CLSD The Nasdaq Stock Mar
• $1.12 — ter) based on the closing sale price of $1.12 as reported on the Nasdaq Global Market
• $14.3 billion — d aggregate 2020 sales of approximately $14.3 billion globally. Axitinib is currently appro

Filing Documents

• clsd-20231231.htm (10-K) — 2480KB
• clsd-ex10_31.htm (EX-10.31) — 694KB
• clsd-ex10_33.htm (EX-10.33) — 44KB
• clsd-ex10_35.htm (EX-10.35) — 39KB
• clsd-ex23_1.htm (EX-23.1) — 13KB
• clsd-ex31_1.htm (EX-31.1) — 13KB
• clsd-ex31_2.htm (EX-31.2) — 13KB
• clsd-ex32_1.htm (EX-32.1) — 9KB
• clsd-ex97_clawbackpo.htm (EX-97.CLAWBACKPO) — 53KB
• img141503921_0.jpg (GRAPHIC) — 35KB
• img141503921_1.jpg (GRAPHIC) — 45KB
• img141503921_2.jpg (GRAPHIC) — 160KB
• 0000950170-24-030126.txt (&nbsp;) — 10949KB
• clsd-20231231.xsd (EX-101.SCH) — 1448KB
• clsd-20231231_htm.xml (XML) — 1503KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 28 Item 1B. Unresolved Staff Comments 61 Item 1C. Cybersecurity 61 Item 2.

Properties

Properties 61 Item 3.

Legal Proceedings

Legal Proceedings 62 Item 4. Mine Safety Disclosures 62 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 63 Item 6. [Reserved] 63 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 64 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 76 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 77 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 102 Item 9A.

Controls and Procedures

Controls and Procedures 102 Item 9B. Other Information 102 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 102 PART III Item 10. Directors, Executive Officers and Corporate Governance 103 Item 11.

Executive Compensation

Executive Compensation 103 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 103 Item 13. Certain Relationships and Related Transactions, and Director Independence 103 Item 14. Principal Accountant Fees and Services 103 PART IV Item 15. Exhibits, Financial Statement Schedules 104 Item 16 Form 10-K Summary 108

Signatures

Signatures 109 4 Table of Contents PART I

BUSINESS

ITEM 1. BUSINESS Overview We are a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space, or SCS. Our novel SCS injection platform, utilizing our proprietary SCS Microinjector, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Our SCS injection platform can be used in conjunction with existing drugs designed for delivery to the SCS, novel therapies and future therapeutic innovations. We believe our proprietary suprachoroidal administration platform has the potential to become a standard for delivery of therapies intended to treat chorioretinal diseases. We are leveraging our SCS injection platform by building an internal research and development pipeline targeting retinal diseases and by creating external collaborations with other companies. We are developing our own pipeline of small molecule product candidates for administration via our SCS Microinjector, and we also strategically partner with companies developing other ophthalmic therapeutic innovations to be administered using our SCS injection technology. Our first product, XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use, was approved by the U.S. Food and Drug Administration, or the FDA, in October 2021. Approval of XIPERE was a significant milestone for us as it is the first approved therapeutic delivered into the SCS, the first commercial product developed by us and the first therapy for macular edema associated with uveitis. We believe that we are creating a broad therapeutic platform for developing product candidates to treat serious eye diseases. Our Suprachoroidal Space (SCS) Injection Platform Our suprachoroidal injection platform is a novel, patented approach for delivering p

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View this 10-K filing on SEC EDGAR