Sonoma Pharmaceuticals, Inc. annual report, FY2023

Sonoma Pharmaceuticals, Inc. — FY2023 Form 10-K

Reporting period: Fiscal year ended March 31, 2023, compared with fiscal 2022. Although the request metadata says “2022 Q4,” this filing is an annual report for FY2023, not a quarterly filing.

Business context

Sonoma develops and manufactures stabilized hypochlorous acid (HOCl) products for human and animal health care and surface disinfection. It sells directly and through partners in 55 countries; manufacturing is based in Mexico. The company is pursuing product launches, distributor growth and additional regulatory clearances.

Financial performance and liquidity

MetricFY2023FY2022
Revenue$13.272 million$12.628 million
Gross profit / margin$4.477 million / 34%$3.993 million / 32%
Operating loss$4.570 million$5.887 million
Net loss$5.151 million$5.086 million
Basic and diluted loss per share$1.52$1.92
Net cash used in operating activities$6.152 million$4.248 million
Cash and cash equivalents at year-end$3.820 million$7.396 million
Working capital at year-end$10.081 million$10.611 million
  • Revenue rose 5%. Product revenue declined to $11.926 million from $12.179 million, while service and royalty revenue increased to $1.346 million from $449,000.
  • Gross margin improved by two percentage points, which management attributed to factory efficiency and product mix. Selling, general and administrative expense fell 9% to $8.840 million; research and development expense increased 66% to $207,000.
  • U.S. revenue decreased 10% to $3.428 million; Europe increased 19% to $4.051 million. Latin American revenue grew to $2.383 million, including $750,000 from machinery sold to a customer, which management expects to be a one-time event.
  • Operating cash outflow increased primarily because of the loss and a $1.296 million decline in deferred revenue. Financing activities provided $2.489 million, including $2.868 million net proceeds from an at-the-market stock offering and $515,000 in short-term note proceeds.
  • At March 31, 2023, the balance sheet showed $431,000 of short-term debt, no remaining PPP loan, and total liabilities of $8.254 million. Total assets were $16.231 million. The filing also reports $4.235 million of withholding tax payable.

Material changes and notable items

  • Net loss was broadly similar year over year, while operating loss improved; the reported FY2022 net loss included $723,000 of PPP loan forgiveness and a $150,000 gain on asset sales. FY2023 had a $1,000 gain on asset sales.
  • Foreign-currency transaction losses were $692,000 in FY2023 versus $579,000 in FY2022. Currency translation adjustments were positive $894,000 in FY2023.
  • Common shares outstanding increased from approximately 3.101 million to 4.934 million, reflecting ATM issuance and other share activity. The company reported 4,941,596 shares outstanding on June 16, 2023.
  • After year-end, the company announced new U.S. OTC products Podiacyn and Pediacyn, and an anticipated European launch of a pulse-lavage irrigation application in September 2023, with a U.S. launch anticipated in 2024. These are forward-looking plans, not FY2023 results.

Outlook, risks and contingencies

  • Going concern: The auditor’s report and management disclose substantial doubt about the company’s ability to continue as a going concern, citing recurring losses, negative operating cash flow and the need for additional funding. The audited statements assume continued operations and do not include adjustments that might result if the company cannot continue as a going concern.
  • Management expects losses to continue in the foreseeable future and says additional capital may be needed; no assurance is given that financing will be available on acceptable terms. If funding is unavailable, cost reductions could delay commercialization and development. The company did not anticipate material capital expenditures for FY2024.
  • Mexico-related intercompany balances and tax exposure are significant: the subsidiary’s disclosed obligations include approximately $12.3 million principal, $11.1 million technical-assistance payments and $21.8 million accrued interest, maturing in 2027. The company estimates approximately $4.2 million of Mexican withholding tax if interest and technical-assistance amounts were repaid; it also discusses potential tax costs if the intercompany debt were forgiven or converted. Management says it is reviewing options with tax professionals.
  • Revenue and receivables are concentrated: three customers represented 45% of FY2023 revenue, and two customers represented 43% of year-end net receivables. About 74% of FY2023 revenue was generated outside the United States, exposing results to customer, collection, regulatory, currency and geopolitical risks.
  • Other disclosed risks include dependence on distributors, product acceptance and reimbursement, regulatory compliance and manufacturing quality, competition, foreign-exchange volatility, supply-chain and inflation pressures, and the need to protect intellectual property. The company reports $2.5 million of deposits above federally insured limits.
  • Disclosure controls and internal control over financial reporting were assessed as ineffective at March 31, 2023 because of material weaknesses, including spreadsheet controls, separation of duties and revenue-reporting analysis. Remediation actions were underway but had not been tested for a sufficient period to establish effectiveness.
  • The auditor issued an unqualified opinion on the financial statements and reported no critical audit matters; the opinion includes a separate substantial-doubt-about-going-concern section. Management reported no material off-balance-sheet arrangements and described ordinary-course legal matters as currently insignificant.

Important facts for investors to verify

  • Available cash, cash burn and financing needs, including whether new capital can be raised without substantial dilution.
  • Progress toward reducing operating cash outflows and achieving sustainable gross-margin and revenue growth.
  • Customer concentration, distributor purchasing, receivable collection and the sustainability of the one-time machinery sale and higher service revenue.
  • The amount, timing and practical resolution of Mexico intercompany balances and related withholding-tax exposure.
  • Whether internal-control remediation is completed and independently tested, and whether subsequent filings identify any further reporting issues.
  • Regulatory and commercial progress for announced products and applications, including actual launch timing and sales contribution.