ORGS.OTC.PinkOrgenesis INC

10-Q/A: Orgenesis Inc. Restates Q2 2023 Financials Due to Accounting Errors

Sentiment:

Quarterly Report Amendment


Orgenesis Inc. has amended its Q2 2023 quarterly report to restate financials due to errors in revenue recognition and credit loss accounting.

Capital raiseThe company is planning to raise additional capital to fund its operations and repay outstanding loans.The company may need to seek additional financing if operating costs increase or revenues decrease.The company has previously funded its operations through offerings of its securities and convertible loans.
Worse than expectedThe company's revenue decreased significantly, and its net loss increased substantially compared to the same period last year.The company's internal controls were deemed ineffective, indicating a material weakness in financial reporting.The company's cash position has significantly deteriorated, raising concerns about its ability to continue as a going concern.

Summary

  • Orgenesis Inc. has filed an amended quarterly report for the period ended June 30, 2023, to correct previously reported financial statements.
  • The restatement was necessary due to errors in accounting for revenues, equity investees, goodwill, share on loss of associated companies, selling, general and administration expenses, convertible loan receivable and credit losses related to such convertible loan.
  • The company's management reassessed the effectiveness of its disclosure controls and procedures and internal control over financial reporting as of June 30, 2023, and determined they were not effective due to the inappropriate measurement of expected credit losses and revenues.
  • The company reported a net loss of $54.57 million for the six months ended June 30, 2023, compared to a net loss of $9.49 million for the same period in 2022.
  • Revenues for the six months ended June 30, 2023, were $255 thousand, a significant decrease from $14.41 million in the same period of 2022.
  • The company's cash and cash equivalents decreased from $5.31 million at the end of 2022 to $180 thousand as of June 30, 2023.
  • The company deconsolidated Octomera LLC from its financial statements as of June 30, 2023, due to changes in the board composition, resulting in a loss of $5.34 million.

Sentiment

Score: 2

Explanation: The document reveals significant financial and operational issues, including a substantial loss, a major revenue decline, ineffective internal controls, and a going concern warning. The restatement of financials and the deconsolidation of a subsidiary further contribute to a negative outlook.

Positives

  • The company has taken steps to correct the accounting errors by restating its financial statements.
  • The company is exploring additional avenues to increase revenue and reduce capital expenditures.
  • The company is planning to raise additional capital to fund its operations and repay outstanding loans.

Negatives

  • The company experienced a significant decrease in revenue and a substantial increase in net loss.
  • The company's internal controls were deemed ineffective, indicating a material weakness in financial reporting.
  • The company's cash position has significantly deteriorated.
  • The deconsolidation of Octomera resulted in a significant loss.
  • There is substantial doubt about the company's ability to continue as a going concern.

Risks

  • The company's ability to generate sustainable positive cash flows is uncertain.
  • The company may need to seek additional financing or postpone expenses if operating costs increase or revenues decrease.
  • The company's current and projected cash resources raise substantial doubt about its ability to continue as a going concern.
  • The company's internal controls over financial reporting were deemed ineffective.
  • The company is subject to legal proceedings that could have a material impact on its financial condition.

Future Outlook

The company plans to raise additional capital to fund operations and repay outstanding loans, as well as explore additional avenues to increase revenue and reduce expenditures. However, there is no assurance that the company will be able to raise additional capital on acceptable terms, or at all.

Management Comments

  • Management determined that its disclosure controls and procedures and internal control over financial reporting as of June 30, 2023 were not effective as a result of the inappropriate measurement of expected credit losses and revenues.
  • Management plans include raising additional capital to fund the Company's operations and to repay the Company's outstanding loans when they become due, as well as exploring additional avenues to increase revenue and reduce capital expenditures.

Industry Context

The document highlights the challenges faced by biotech companies in scaling cell and gene therapies, particularly in reducing costs and ensuring accessibility. Orgenesis's POCare model is presented as an alternative to traditional drug development, aiming to address these challenges. The company's focus on autologous therapies and decentralized production aligns with industry trends towards personalized medicine and point-of-care solutions.

Comparison to Industry Standards

  • The significant decrease in revenue and increase in net loss are concerning when compared to industry benchmarks for biotech companies in the development stage.
  • The restatement of financials and identification of material weaknesses in internal controls are not typical for companies of this size and stage, indicating potential issues with financial management and governance.
  • The company's cash burn rate and liquidity position are significantly worse than many comparable companies, raising concerns about its ability to continue operations without additional funding.
  • While the POCare model is innovative, its financial performance is not yet demonstrating the potential for scalability and profitability seen in other successful biotech companies.
  • The deconsolidation of Octomera and the resulting loss are unusual and suggest a significant shift in the company's strategy and structure, which may not be viewed positively by investors.

Management Changes

RolePrevious PersonNew PersonEffective DateReason
Chief Financial Officer, Treasurer and SecretaryNeil ReithingerElliot Maltz2023-09-01Neil Reithinger resigned to pursue other opportunities.
Chief Development OfficerEfrat Assa Kunik2023-07-11Efrat Assa Kunik resigned to pursue other opportunities.

Corporate Governance

Change TypeDescriptionEffective DateImpact Assessment
Internal ControlThe company's management reassessed the effectiveness of its disclosure controls and procedures and internal control over financial reporting as of June 30, 2023, and determined they were not effective due to the inappropriate measurement of expected credit losses and revenues.2023-06-30The company identified a material weakness in its internal control over financial reporting, which contributed to the restatement of its financial statements.

Legal Proceedings

  • The company is involved in a legal proceeding in the Tel Aviv District Court, where the plaintiffs are seeking royalties and financial statements related to a license agreement.

Related Party Transactions

  • The company has related party transactions with Octomera LLC, including investments and loans.
  • The company has related party transactions with certain customers.

Stakeholder Impact

  • Shareholders will be negatively impacted by the restatement of financials, the significant increase in net loss, and the decrease in cash position.
  • Employees may be affected by potential cost-cutting measures or restructuring due to the company's financial difficulties.
  • Customers may be concerned about the company's ability to continue operations and fulfill its obligations.
  • Creditors may be concerned about the company's ability to repay its debts.
  • Suppliers may be concerned about the company's ability to pay for goods and services.

Next Steps

  • The company plans to raise additional capital to fund its operations.
  • The company will explore additional avenues to increase revenue and reduce capital expenditures.
  • The company will continue to address the material weakness in its internal control over financial reporting.

Key Dates

DateDescription
2018-11-03Date of 2% Notes purchased from the Company by Nir.
2019-05-17Date of Convertible Loan Agreement with Nir.
2019-10-03Date of Convertible Credit Line Agreement with Dotan and Lukach.
2022-01-17Date of complaint filed against the company in the Tel Aviv District Court.
2022-04-12Date of Convertible Loan Agreement with Nir.
2023-01-10Effective date of convertible loan agreements with NewTech Lender and Malik Lender.
2023-01-12Date of extension agreements for convertible loans with Dotan, Lukach, and Nir.
2023-02-23Date of securities purchase agreement for issuance of shares and warrants.
2023-03-27Date of convertible loan agreement between Koligo Therapeutics Inc. and Yehuda Nir.
2023-05-05Date of Amendment No. 1 to the Unit Purchase Agreement with MM.
2023-06-30End of the reporting period and date of deconsolidation of Octomera LLC.
2023-07-06Neil Reithinger informed the Company of his decision to resign as Chief Financial Officer.
2023-07-11Efrat Assa Kunik informed the Company of her decision to resign as Chief Development Officer.
2023-07-25Israeli Subsidiary received a loan from an offshore investor and the company entered into a settlement and release agreement with Mircod LLC.
2023-08-10Original filing date of the Quarterly Report on Form 10-Q.
2024-04-10Audit Committee concluded that certain items of the Companys previously issued unaudited condensed consolidated interim financial statements should no longer be relied upon.
2024-04-15Date of filing of the amended Quarterly Report on Form 10-Q/A.

Keywords

restatement, financial statements, accounting errors, revenue recognition, credit losses, internal controls, net loss, deconsolidation, convertible loans, going concern, POCare, cell therapy

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