REGENXBIO Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>REGENXBIO Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations.</b>

AI Summary

REGENXBIO Inc. (RGNX) filed a Annual Report (10-K) with the SEC on February 27, 2024. REGENXBIO Inc. filed its 2023 Form 10-K on February 27, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located at 9804 Medical Center Drive, Rockville, MD 20850. REGENXBIO Inc. is classified under SIC code 2836 for Biological Products (No Diagnostic Substances). The filing references various agreements including those with Abeona Therapeutics, GlaxoSmithKline LLC, and AbbVie.

Why It Matters

For investors and stakeholders tracking REGENXBIO Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of REGENXBIO's financial health, operational activities, and strategic partnerships for the fiscal year 2023, which is crucial for investors to assess the company's current standing and future prospects. The detailed information on revenue, expenses, assets, and liabilities, along with disclosures on risks and legal matters, allows stakeholders to make informed investment decisions and understand the company's regulatory and market environment.

Risk Assessment

Risk Level: medium — REGENXBIO Inc. shows moderate risk based on this filing. The company operates in the biotechnology sector, which is inherently risky due to long development cycles, high R&D costs, and regulatory hurdles, as evidenced by the nature of its business and the mention of various collaboration and license agreements.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand REGENXBIO's financial position and the potential challenges in its gene therapy development pipeline.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-27 — Filing Date (Date of submission)
• 240-552-8181 — Business Phone (Contact number)
• 001-37553 — SEC File Number (SEC registration number)
• 0000950170-24-021161 — Accession Number (Unique identifier for the filing)

Key Players & Entities

• REGENXBIO Inc. (company) — Filer name
• Abeona Therapeutics Incorporation (company) — Mentioned in relation to contract termination
• GlaxoSmithKline LLC (company) — Mentioned in relation to General and Administrative Expense
• AbbVie (company) — Mentioned in relation to collaboration and license agreements
• 2023-12-31 (date) — Fiscal year end
• 2024-02-27 (date) — Filing date
• Rockville, MD (location) — Business address
• 2836 (industry_code) — Standard Industrial Classification

FAQ

Risk Factors

• Customer Concentration Risk [medium — market]: The company faces risks related to customer concentration, particularly concerning sales revenue from non-US markets.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-02-27: Filing Date — Date the 10-K was officially submitted to the SEC.

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share RGNX The Nasdaq Global Se

Filing Documents

• rgnx-20231231.htm (10-K) — 3805KB
• rgnx-ex10_9.htm (EX-10.9) — 358KB
• rgnx-ex21_1.htm (EX-21.1) — 4KB
• rgnx-ex23_1.htm (EX-23.1) — 3KB
• rgnx-ex31_1.htm (EX-31.1) — 12KB
• rgnx-ex31_2.htm (EX-31.2) — 12KB
• rgnx-ex32_1.htm (EX-32.1) — 11KB
• rgnx-ex97_1.htm (EX-97.1) — 36KB
• img149531916_0.jpg (GRAPHIC) — 344KB
• img149531916_1.jpg (GRAPHIC) — 67KB
• img149531916_2.jpg (GRAPHIC) — 253KB
• 0000950170-24-021161.txt (&nbsp;) — 17451KB
• rgnx-20231231.xsd (EX-101.SCH) — 2014KB
• rgnx-20231231_htm.xml (XML) — 3215KB

Business

Business 2 Item 1A.

Risk Factors

Risk Factors 29 Item 1B. Unresolved Staff Comments 62 Item 1C. Cybersecurity 62 Item 2.

Properties

Properties 63 Item 3.

Legal Proceedings

Legal Proceedings 63 Item 4. Mine Safety Disclosures 63 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 64 Item 6. Reserved 65 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 66 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 80 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 80 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 80 Item 9A.

Controls and Procedures

Controls and Procedures 80 Item 9B. Other Information 82 Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 82 Part III Item 10. Directors, Executive Officers and Corporate Governance 83 Item 11.

Executive Compensation

Executive Compensation 83 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 83 Item 13. Certain Relationships and Related Transactions, and Director Independence 83 Item 14. Principal Accountant Fees and Services 83 Part IV Item 15. Exhibits, Financial Statement Schedules 84 Item 16. Form 10-K Summary 84 Index to Consolidated Financial Statements 85 Exhibit Index 124

Signatures

Signatures 127 Table of Contents PART I INFORMATION REGARDING FO RWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as "anticipate," "assume," "believe," "continue," "could," "design," "estimate," "expect," "forecast," "goal," "intend," "may," "objective," "plan," "position," "potential," "predict," "project," "seek," "should," "will," "would" or variations of such words or by similar expressions. We have based these forward-looking statements on our current expectations, estimates and assumptions and analyses in light of our experience and our perception of historical trends, current conditions and expected future developments, as well as other factors we believe are appropriate under the circumstances. However, whether actual results and developments will conform with our expectations and predictions is subject to a number of risks, uncertainties, assumptions and other important factors, including, but not limited to: our ability to establish and maintain development partnerships, including our collaboration with AbbVie to develop and commercialize ABBV-RGX-314; our ability to obtain and maintain regulatory approval of our product candidates and the labeling for any approved products; the timing of enrollment, commencement, completion and the success of our AAVIATE , AFFINITY BEYOND, AFFINITY DUCHENNE , ALTITUDE , ASCENT, ATMOSPHERE and CAMPSIITE , clinical trials; the timing of commencement and completion and the success of preclinical studies conducted by us and our development partners; the timely development and launch of new products; the scope, progress, expansio

BU SINESS

ITEM 1. BU SINESS Overview We are a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. Our investigational gene therapies are designed to deliver functional genes to address genetic defects in cells, enabling the production of therapeutic proteins or antibodies that are intended to impact disease. Through a single administration, gene therapy could potentially alter the course of disease significantly and deliver improved patient outcomes with long-lasting effects. Our investigational gene therapies use adeno-associated virus (AAV) vectors from our proprietary gene delivery platform, which we call our NAV Technology Platform. AAV vectors are non-replicating viral delivery vehicles that are not known to cause disease. Our NAV Technology Platform consists of exclusive rights to a large portfolio of AAV vectors (NAV Vectors), including commonly used AAV8 and AAV9. We believe this platform forms a strong foundation for our current clinical-stage programs and, with our ongoing research and development, we expect to continue to expand our platform and pipeline of potential AAV vector-based gene therapies. We refer to commercial and investigational AAV vector-based gene therapies as AAV Therapeutics. Our NAV Technology Platform is the foundation for commercial and investigational AAV Therapeutics that have treated thousands of patients through our clinical pipeline and NAV licensees. We have developed a broad pipeline of investigational AAV Therapeutics using our NAV Technology Platform as a one-time treatment to address an array of diseases. We are currently focusing our internal development pipeline in three areas: retinal, neuromuscular and neurodegenerative diseases. We believe these product candidates are differentiated, can be expedited, and support meaningful near-term and long-term value generation. Our investigational AAV Therapeutics include: ABBV-RGX-314, which we are developing in coll

View Full Filing

View this 10-K filing on SEC EDGAR