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

TL;DR

<b>Orgenesis Inc. has filed its annual 10-K report for the fiscal year ending December 31, 2023, detailing its financial performance and business operations.</b>

AI Summary

Orgenesis Inc. (ORGS) filed a Annual Report (10-K) with the SEC on April 15, 2024. Orgenesis Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal business address is 20271 Goldenrod Lane, Germantown, MD 20876. Orgenesis Inc. was formerly known as Orgenesis, Inc. and Business Outsourcing Service, Inc. The company is incorporated in Nevada (NV).

Why It Matters

For investors and stakeholders tracking Orgenesis Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Orgenesis Inc.'s financial health and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The report includes detailed financial statements and disclosures, offering insights into the company's revenue, expenses, assets, and liabilities, enabling stakeholders to make informed investment decisions.

Risk Assessment

Risk Level: — Orgenesis Inc. shows moderate risk based on this filing. The filing is a standard 10-K, which typically contains a broad range of information. However, without specific financial data or operational highlights from the provided text, it's difficult to assess the immediate risk level beyond the standard disclosures expected in such a report.

Analyst Insight

Review the full 10-K filing for detailed financial statements, management's discussion and analysis, and risk factors to understand Orgenesis Inc.'s current financial position and future outlook.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-04-15 — Filing Date (Date of submission)
• 2834 — Standard Industrial Classification (Industry code for Pharmaceutical Preparations)
• NV — State of Incorporation (Legal domicile)

Key Players & Entities

• Orgenesis Inc. (company) — Filer name
• 2023-12-31 (date) — Fiscal year end
• 2024-04-15 (date) — Filing date
• 20271 Goldenrod Lane (address) — Business address
• Germantown (location) — Business address city
• MD (location) — Business address state
• NV (location) — State of incorporation
• 0001460602 (company) — Central Index Key

FAQ

Industry Context

Orgenesis Inc. operates in the Pharmaceutical Preparations industry (SIC code 2834). This sector involves the manufacturing of drugs and medicines.

Regulatory Implications

The filing is a Form 10-K, a mandatory annual report required by the U.S. Securities and Exchange Commission (SEC) for publicly traded companies.

What Investors Should Do

1. Thoroughly review the financial statements and Management's Discussion and Analysis (MD&A) section of the 10-K for detailed insights into Orgenesis Inc.'s financial performance.
2. Examine the 'Risk Factors' section of the 10-K to understand potential challenges and uncertainties facing the company.
3. Compare the current year's financial data with previous years to identify trends and assess the company's growth trajectory.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-04-15: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This is the initial filing data provided for the 2023 10-K. Comparative data from previous filings would be needed for a direct comparison.

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share ORGS The Nasdaq Capital M

Filing Documents

• form10-k.htm (10-K) — 3421KB
• ex21-1.htm (EX-21.1) — 5KB
• ex23-1.htm (EX-23.1) — 5KB
• ex31-1.htm (EX-31.1) — 11KB
• ex31-2.htm (EX-31.2) — 11KB
• ex32-1.htm (EX-32.1) — 5KB
• ex32-2.htm (EX-32.2) — 6KB
• form10-k_001.jpg (GRAPHIC) — 10KB
• form10-k_002.jpg (GRAPHIC) — 102KB
• form10-k_003.jpg (GRAPHIC) — 35KB
• form10-k_004.jpg (GRAPHIC) — 20KB
• form10-k_005.jpg (GRAPHIC) — 18KB
• form10-k_006.jpg (GRAPHIC) — 6KB
• ex23-1_001.jpg (GRAPHIC) — 6KB
• 0001493152-24-014652.txt (&nbsp;) — 15777KB
• orgs-20231231.xsd (EX-101.SCH) — 106KB
• orgs-20231231_cal.xml (EX-101.CAL) — 104KB
• orgs-20231231_def.xml (EX-101.DEF) — 465KB
• orgs-20231231_lab.xml (EX-101.LAB) — 726KB
• orgs-20231231_pre.xml (EX-101.PRE) — 600KB
• form10-k_htm.xml (XML) — 2953KB

RISK FACTORS

ITEM 1A. RISK FACTORS 24

UNRESOLVED STAFF COMMENTS

ITEM 1B. UNRESOLVED STAFF COMMENTS 47

CYBERSECURITY

ITEM 1C. CYBERSECURITY 47

PROPERTIES

ITEM 2. PROPERTIES 50

LEGAL PROCEEDINGS

ITEM 3. LEGAL PROCEEDINGS 50

MINE SAFETY DISCLOSURES

ITEM 4. MINE SAFETY DISCLOSURES 50 PART II

MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 50

[RESERVED]

ITEM 6. [RESERVED] 51

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 51

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 62

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 62

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 62

CONTROLS AND PROCEDURES

ITEM 9A. CONTROLS AND PROCEDURES 62

OTHER INFORMATION

ITEM 9B. OTHER INFORMATION 63

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 63 PART III

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 63

EXECUTIVE COMPENSATION

ITEM 11. EXECUTIVE COMPENSATION 68

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 74

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 78

PRINCIPAL ACCOUNTANT FEES AND SERVICES

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 79 PART IV

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 80

FORM 10-K SUMMARY

ITEM 16. FORM 10-K SUMMARY 82

SIGNATURES

SIGNATURES 83 2 SPECIAL CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS The following discussion should be read in conjunction with the financial statements and related notes contained elsewhere in this Annual Report on Form 10-K. Certain statements made in this discussion are "forward-looking statements" within the meaning of 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based upon beliefs of, and information currently available to, the Company's management as well as estimates and assumptions made by the Company's management. Readers are cautioned not to place undue reliance on these forward-looking "estimate," "expect," "forecast," "future," "intend," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue" or the negative of these terms and similar expressions as they relate to the Company or the Company's management identify forward-looking statements. Such statements reflect the current view of the Company with respect to future events and are subject to risks, uncertainties, assumptions, and other factors, including the risks relating to the Company's business, industry, and the Company's operations and results of operations. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee future results, levels of activity, performance, or achievements. Except as required by applicable law, including the securities laws of the United States, the Company does

Business

Business Overview We are a global biotech company working to unlock the potential of cell and gene therapies ("CGTs") in an affordable and accessible format. CGTs can be centered on autologous (using the patient's own cells) or allogenic (using master banked donor cells) and are part of a class of medicines referred to as advanced therapy medicinal products ("ATMPs"). We are mostly focused on autologous therapies that can be manufactured under processes and systems that are developed for each therapy using a closed and automated approach that is validated for compliant production near the patient for treatment of the patient at the point of care ("POCare"). This approach has the potential to overcome the limitations of traditional commercial manufacturing methods that do not translate well to commercial production of advanced therapies due to their cost prohibitive nature and complex logistics to deliver such treatments to patients (ultimately limiting the number of patients that can have access to, or can afford, these therapies). Advanced Therapy Medicinal Products and POCare Overview ATMP means one of any of the following medicinal products that are developed and commercialized for human use: A somatic cell therapy medicinal product ("STMP") that contains cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body; A tissue engineered produc t ("TEP") that contains cells or tissues that have been modified so that they can be used to repair, regenerate, or replace human tissue; or A gene therapy medicinal product ("GTMP") that engineers genes that lead to a therapeutic, prophylactic, or diagnostic effect and, in many cases, work by inserting "recombinant" genes into the body, usually to treat a variety of diseases, including genetic disorders, cancer, or long-term diseases. In this case, a recombinant gene is a stretch of DNA that is crea

View Full Filing

View this 10-K filing on SEC EDGAR