INTELLIGENT BIO SOLUTIONS INC. annual report, FY2021

SEC Form 10-K Summary

Filing identity and period: The supplied filing is GBS Inc.’s Annual Report on Form 10-K for the fiscal year ended June 30, 2021, filed September 15, 2021. The request metadata identifies Intelligent Bio Solutions Inc. and “2020 Q4,” but the filing text identifies the registrant as GBS Inc. and reports a full fiscal year, not a quarterly period.

Business Context

GBS is an early-stage biosensor diagnostic company developing a saliva-based glucose monitoring system and a SARS-CoV-2 antibody test using licensed organic thin-film transistor technology. The company targets global commercialization of the COV2 test and APAC commercialization of the Saliva Glucose Test, initially focusing on China and other APAC markets.

  • The Saliva Glucose Biosensor remained in development and validation; neither the glucose test nor the COV2 test had received regulatory approval or launched commercially.
  • GBS is controlled by or affiliated with Life Science Biosensor Diagnostics Pty Ltd. (“LSBD”), which held approximately 42.6% of voting rights at June 30, 2021 and owns the underlying intellectual property.
  • The company had seven full-time and two part-time employees and relied on contractors, collaborators, consultants and university partners.

Financial Results and Key Metrics

MetricFiscal 2021Fiscal 2020Change
Government support income$1.980 million$0.070 million+$1.911 million
Shared services revenue$0$0.119 million-$0.119 million
Total reported revenue/income$1.980 million$0.189 million+$1.792 million
Operating expenses$7.554 million$3.046 million+$4.508 million
Loss from operations$(5.573) million$(2.857) millionLoss increased $2.716 million
Net loss attributable to GBS$(7.037) million$(3.164) millionLoss increased $3.874 million
Basic and diluted loss per share$(0.68)$(0.37)Loss per share worsened
Cash and cash equivalents$12.574 million$0.427 million+$12.146 million
Working capital$14.524 millionNot clearly providedNot clearly comparable
Net cash used in operating activities$(11.296) million$(0.499) millionCash burn increased

The company stated that it had generated no commercial product revenue to date. Fiscal 2021 reported income was primarily government support, including approximately $1.85 million of research and development tax refund income and other COVID-19-related support. Gross margin and product margins were not meaningful because the company had not commercialized its products.

General and administrative expense increased to $3.359 million from $2.203 million, while development and regulatory expense increased to $3.836 million from $0.588 million. The latter included increased product development activity following the IPO and a $0.5 million expense for the North American license option.

Liquidity, Capitalization and Debt

  • GBS completed its initial public offering in December 2020 and reported net proceeds of approximately $17.732 million after underwriting discounts, commissions and offering costs.
  • Convertible notes with $5.134 million of principal converted into 710,548 common shares at the IPO. No convertible notes remained outstanding at June 30, 2021.
  • Total liabilities were $6.853 million, including $5.247 million of deferred grant income and $1.570 million of accounts payable and accrued expenses. The filing does not identify material interest-bearing debt outstanding at year-end.
  • Management believed available capital would fund operations for at least 15 months from the filing date, but expected continued operating losses and no near-term positive operating cash flow.
  • The company had an accumulated deficit of $22.870 million at June 30, 2021 and stated that additional financing could be required earlier than anticipated.

Material Changes Versus the Prior Period

  • Loss attributable to GBS more than doubled, primarily because the company expanded development, regulatory and operating activities after the IPO.
  • Operating cash burn increased substantially to $11.296 million from $0.499 million.
  • Cash increased significantly because of IPO proceeds, preferred stock issuance and warrant exercises, partially offset by operating expenditures and equity issuance costs.
  • Interest expense increased to $1.094 million, including a $0.906 million non-cash beneficial conversion feature recognized when the convertible notes converted.
  • The company incurred a $0.271 million realized foreign exchange loss and a $0.297 million foreign currency translation loss.
  • GBS entered into a two-year option to acquire an exclusive North American glucose license for a $5 million exercise price. The $0.5 million option fee was expensed.
  • The company received approval for up to $4.7 million of Australian government grant funding to support a high-tech manufacturing facility, subject to achievement of specified deliverables. Separately, the financial statements recognized a grant with total value of up to $5.24 million as a receivable and deferred grant income.

Guidance, Outlook, Risks and Unusual Items

Management did not provide quantitative revenue or earnings guidance. It expected no near-term commercial revenue until product development, regulatory approval and market acceptance were achieved. Future expenses were expected to increase as development, regulatory, manufacturing, marketing and distribution activities expanded.

  • Regulatory and clinical risk: Neither principal product had regulatory approval. Clinical results, FDA or other jurisdictional review, and the timing of approvals remained uncertain.
  • Commercialization risk: The company had no commercial sales, limited operating history and no assurance that customers, payors or distributors would adopt its products.
  • Funding risk: Continued losses and negative operating cash flow may require additional equity or debt financing, potentially on unfavorable terms or with dilution.
  • Manufacturing risk: The mass-market manufacturing plan had not been finalized, and the company expected to rely on third-party manufacturers and suppliers.
  • License and related-party risk: The core technology is licensed from LSBD, a major shareholder with significant voting influence. The license includes territorial restrictions, minimum royalty provisions after regulatory approval and restrictions on suppliers and sublicensing.
  • Grant contingency: Grant proceeds depend on specified deliverables. The filing’s grant disclosures should be reconciled because the business discussion refers to $4.7 million while the accounting note describes a grant with total value of up to $5.24 million.
  • Internal controls: Management concluded that disclosure controls were not effective at June 30, 2021 because of a material weakness in the control environment, documentation, review evidence and available accounting resources.
  • Unusual financing items: The company had substantial outstanding warrants, including warrants for 3.0 million shares issued to LSBD at a $17 exercise price and 2.737 million pre-IPO warrants exercisable at $8.50 during years two through three after the IPO.
  • Commitments: The company owed approximately $211,795 under a Johns Hopkins sponsored research agreement and $152,344 under a Harvard research collaboration agreement at year-end.

Investor Verification Priorities

  • Confirm that the correct issuer and reporting period are being analyzed; the filing is for GBS Inc., fiscal year ended June 30, 2021.
  • Reconcile government support income, grant receivables and deferred grant income, including the $4.7 million versus $5.24 million grant references.
  • Verify the absence of commercial product revenue and distinguish government support income from operating revenue.
  • Review the company’s cash runway against annual operating cash burn of $11.296 million and its stated expectation of continued losses.
  • Assess progress toward FDA, NMPA and other regulatory approvals and the status of clinical studies for both products.
  • Review the terms, exercise price and potential dilution from outstanding warrants and convertible preferred stock.
  • Evaluate the $5 million North American license option, related-party transactions with LSBD, royalty obligations and LSBD’s 42.6% voting control.
  • Monitor remediation of the material weakness in internal control over financial reporting.