ProQR Therapeutics N.V. Files 20-F Annual Report for Fiscal Year 2023

TL;DR

<b>ProQR Therapeutics N.V. has filed its 20-F annual report for the fiscal year ending December 31, 2023, providing a comprehensive overview of its operations and financial standing.</b>

AI Summary

ProQR Therapeutics N.V. (PRQR) filed a Foreign Annual Report (20-F) with the SEC on March 13, 2024. ProQR Therapeutics N.V. filed its 20-F annual report for the fiscal year ending December 31, 2023. The company's principal executive offices are located at Zernikedreef 9, Leiden, Netherlands. The filing covers the fiscal year 2023, with data as of December 31, 2023. Key dates mentioned include various agreements and financing events throughout 2021, 2022, and 2023. The report details financial information, including convertible debt and stock option scenarios.

Why It Matters

For investors and stakeholders tracking ProQR Therapeutics N.V., this filing contains several important signals. This filing provides investors with the latest financial statements and operational updates for ProQR Therapeutics N.V., crucial for assessing the company's performance and future prospects. The 20-F report is a mandatory filing for foreign private issuers like ProQR Therapeutics N.V., offering detailed insights into their business, financial condition, and risk factors.

Risk Assessment

Risk Level: medium — ProQR Therapeutics N.V. shows moderate risk based on this filing. The company's financial health and future prospects are subject to the inherent risks of the pharmaceutical industry, including clinical trial outcomes and regulatory approvals, as indicated by the numerous specific agreements and financing events detailed in the filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors within the 20-F filing to understand ProQR Therapeutics N.V.'s current financial position and strategic direction.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-13 — Filing Date (Date the 20-F was filed)
• 122 — Public Document Count (Number of documents in the filing)
• 2834 — SIC Code (Standard Industrial Classification for Pharmaceutical Preparations)

Key Players & Entities

• ProQR Therapeutics N.V. (company) — Filer of the 20-F report
• 2023-12-31 (date) — Fiscal year end date
• Zernikedreef 9, Leiden, Netherlands (location) — Business and mailing address
• Eli Lilly and Company (company) — Mentioned in relation to an agreement dated 2021-09-30
• Pontifax Medison and Kreos Capital (company) — Related to convertible debt financing
• Foundation Fighting Blindness (FFB) (company) — Related to a clinical support agreement
• Cantor Fitzgerald & Co. (company) — Related to an at-market offering
• USD (currency) — Currency for risk assessment

FAQ

Risk Factors

• Convertible Debt Financing [medium — financial]: The company has entered into agreements for convertible debt financing with entities like Pontifax Medison and Kreos Capital, which carry specific terms and conditions.
• Stock Options and RSUs [medium — financial]: The filing outlines scenarios for stock options and restricted stock units (RSUs), including vesting schedules and potential impacts on equity.
• Clinical Support Agreement [low — regulatory]: A clinical support agreement with the Foundation Fighting Blindness (FFB) is mentioned, indicating potential collaborations and dependencies.
• Currency Risk [medium — financial]: The company is exposed to currency risk, particularly with the USD, for the periods 2022 and 2023.
• Interest Rate Risk [low — financial]: The company is exposed to interest rate risk for the period 2023.

Filing Documents

• tmb-20231231x20f.htm (20-F) — 3839KB
• tmb-20231231xex8d1.htm (EX-8.1) — 8KB
• tmb-20231231xex12d1.htm (EX-12.1) — 13KB
• tmb-20231231xex12d2.htm (EX-12.2) — 13KB
• tmb-20231231xex13d1.htm (EX-13.1) — 17KB
• tmb-20231231xex15d1.htm (EX-15.1) — 3KB
• tmb-20231231xex97d1.htm (EX-97.1) — 37KB
• tmb-20231231x20f001.jpg (GRAPHIC) — 93KB
• tmb-20231231x20f002.jpg (GRAPHIC) — 51KB
• tmb-20231231x20f003.jpg (GRAPHIC) — 79KB
• tmb-20231231x20f004.jpg (GRAPHIC) — 60KB
• 0001558370-24-003060.txt (&nbsp;) — 14482KB
• tmb-20231231.xsd (EX-101.SCH) — 107KB
• tmb-20231231_cal.xml (EX-101.CAL) — 83KB
• tmb-20231231_def.xml (EX-101.DEF) — 317KB
• tmb-20231231_lab.xml (EX-101.LAB) — 680KB
• tmb-20231231_pre.xml (EX-101.PRE) — 533KB
• tmb-20231231x20f_htm.xml (XML) — 2810KB

Item 18

Item 17 Item 18 If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No Table of Contents Summary of the Material and Other Risks Associated with Our Business Our business is subject to numerous material risks and uncertainties that you should be aware of in evaluating our business, including those described in Part I, Item 3.D: "Risk Factors" in this Annual Report on Form 20-F, or this Annual Report. These risks include, but are not limited to, the following: We are a biopharmaceutical company with a history of losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability, which could result in a decline in the market value of our ordinary shares. We will require additional capital to fund our operations and if we fail to obtain the necessary financing, we will not be able to complete the development and commercialization of our product candidates. While we were founded in 2012, we announced our plans to refocus our business on our RNA editing platforms in 2022, and it may make it difficult to assess the future viability of our business and our strategy. Our business depends in part on the success of our product candidates, which are currently in early phases of preclinical development. We cannot be certain that we will be able to successfully complete the clinical development of, obtain regulatory approval for, or successfully commercialize our product candidates. We may not be able to file investigational new drug applications ("INDs") or IND amendments or similar applications to commence clinical trials of our product candidates on the timelines we expect, and even if we are able to, the U.S. Food and Drug Administration (the "FDA") or similar foreign regulatory authority may not permit us to proceed. The regulatory approval processes of the FDA, the European Medicines Agency (the "EMA")

: Identity of Directors, Senior Management and Advisers

Item 1 : Identity of Directors, Senior Management and Advisers 7

: Offer Statistics and Expected Timetable

Item 2 : Offer Statistics and Expected Timetable 7

: Key Information

Item 3 : Key Information 7 A. [Reserved] 7 B. Capitalization and Indebtedness 7 C. Reasons for the Offer and Use of Proceeds 7 D. Risk Factors 7

: Information on the Company

Item 4 : Information on the Company 57 7 A. History and Development of the Company 57 B. Business Overview 58 C. Organizational Structure 89 D. Property, Plants and Equipment 89

: Unresolved Staff Comments

Item 4A : Unresolved Staff Comments 89

: Operating and Financial Review and Prospects

Item 5 : Operating and Financial Review and Prospects 89 A. Operating Results 90 B. Liquidity and Capital Resources 96 3 C. Research and Development 101 D. Trend Information 101 E. Critical accounting policies and Significant Judgments and Estimates 101

: Directors, Senior Management and Employees

Item 6 : Directors, Senior Management and Employees 101 A. Directors and Senior Management 101 B. Compensation 104 C. Board Practices 106 D. Employees 111 E. Share Ownership 111

: Major Shareholders and Related Party Transactions

Item 7 : Major Shareholders and Related Party Transactions 111 A. Major shareholders 111 B. Related Party Transactions 113 C. Interests of Experts and Counsel 113

: Financial Information

Item 8 : Financial Information 113 A. Consolidated Statements and Other Financial Information 113 B. Significant Changes 114 1 Table of Contents

: The Offer and Listing

Item 9 : The Offer and Listing 114 A. Offering and Listing Details 114 B. Plan of Distribution 114 C. Markets 114 D. Selling Shareholders 114 E. Dilution 115 F. Expenses of the Issue 115

: Additional Information

Item 10 : Additional Information 115 A. Share Capital 115 B. Memorandum and Articles of Association 115 C. Material Contracts 125 D. Exchange Controls 125 E. Taxation 126 F. Dividends and Paying Agents 135 G. Statement by Experts 135 H. Documents on Display 135 I. Subsidiary Information 136 J. Annual Report to Security Holders 136

: Quantitative and Qualitative Disclosures about Market Risk

Item 11 : Quantitative and Qualitative Disclosures about Market Risk 136

: Description of Securities other that Equity Securities

Item 12 : Description of Securities other that Equity Securities 137 A. Debt Securities 137 B. Warrants and Rights 137 C. Other Securities 137 D. American Depositary Shares 137 Part II 138

: Defaults, Dividend Arrearages and Delinquencies

Item 13 : Defaults, Dividend Arrearages and Delinquencies 138

: Material Modifications to the Rights of Security Holders and Use of Proceeds

Item 14 : Material Modifications to the Rights of Security Holders and Use of Proceeds 138

: Controls and Procedures

Item 15 : Controls and Procedures 138 A. Disclosure Controls and Procedures 138 B. Management's Annual Report on Internal Control over Financial Reporting 138 C. Attestation Report of the Registered Public Accounting Firm 139 D. Changes in Internal Control over Financial Reporting 140

: [Reserved]

Item 16: [Reserved] 140

: Audit Committee Financial Expert

Item 16A : Audit Committee Financial Expert 140 2 Table of Contents

: Code of Ethics

Item 16B : Code of Ethics 140

: Principal Accountant Fees and Services

Item 16C : Principal Accountant Fees and Services 140

: Exemptions from the Listing Standards for Audit Committees

Item 16D : Exemptions from the Listing Standards for Audit Committees 140

: Purchases of Equity Securities by the Issuer and Affiliated Purchasers

Item 16E : Purchases of Equity Securities by the Issuer and Affiliated Purchasers 140

: Change in Registrant's Certifying Accountant

Item 16F : Change in Registrant's Certifying Accountant 141

: Corporate Governance

Item 16G : Corporate Governance 141

: Mine Safety Disclosure

Item 16H : Mine Safety Disclosure 141

: Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 16I: Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 142

: Insider trading policies

Item 16J: Insider trading policies 142

: Cybersecurity

Item 16K: Cybersecurity 142 Part III 143

: Financial Statements

Item 17 : Financial Statements 143

: Financial Statements

Item 18 : Financial Statements 143

: Exhibits

Item 19 : Exhibits 143 From time to time, we may use our website or our LinkedIn profile at www.linkedin.com/company/proqr-therapeutics/ to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors & Media section of our website, available at www.ProQR.com. Investors are encouraged to review the Investors & Media section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our LinkedIn page is not incorporated into, and does not form a part of, this Annual Report on Form 20-F. 3 Table of Contents Introduction This document contains information required for the Annual Report on Form 20-F for the year ended December 31, 2023, of ProQR Therapeutics N.V. (the "Annual Report"). Unless the context specifically indicates otherwise, references in this Annual Report to "ProQR Therapeutics N.V.", "ProQR Therapeutics", "ProQR", "we", "our", "ours", "us", the "Company" and similar designations refer to ProQR Therapeutics N.V., a company organized under the laws of the Netherlands, and where appropriate, its consolidated subsidiaries. IFRS Based Information The audited financial statements as at December 31, 2023 and 2022, and for the years ended December 31, 2023, December 31, 2022 and December 31, 2021, included in the Annual Report have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB"). Non-GAAP Information In presenting and discussing our financial position, operating results and cash flows, management uses certain non-GAAP financial measures. These non-GAAP financial measures should not be viewed in isolation as alternatives to the equivalent IFRS measure and should be used in conjunction with the most directly comparable IFRS measure(s). Exchange Rates

: Identity of Directors, Senior Management and Advisers

Item 1: Identity of Directors, Senior Management and Advisers Not applicable.

: Offer Statistics and Expected Timetable

Item 2: Offer Statistics and Expected Timetable Not applicable.

: Key Information

Item 3: Key Information A. [Reserved] Not applicable. B. Capitalization and Indebtedness Not applicable. C. Reasons for the Offer and Use of Proceeds Not applicable. D. Risk Factors You should consider carefully the risks and uncertainties described below, together with all of the other information in this Annual Report, including the financial statements and the related notes included elsewhere in this Annual Report. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business. If any of the following risks actually occurs, our business, financial condition, results of operations, and future prospects could be materially and adversely affected. Risks Related to Our Capital Needs and Financial Position We are a biopharmaceutical company with a history of losses. We expe

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View this 20-F filing on SEC EDGAR