Smartkem, Inc. annual report, FY2021

SmartKem, Inc. — FY2021 Form 10-K

Business context and reporting period. This annual report covers the year ended December 31, 2021, with 2020 comparisons. SmartKem develops TRUFLEX organic thin-film transistor materials and processes for flexible electronics. It remains at a development and demonstration stage: reported revenue came from demonstration products, and the company had not commercialized products. In February 2021, the company completed a reverse recapitalization with SmartKem Limited and raised equity financing.

Financial performance and position

  • Revenue and gross profit: Revenue was $18,000, down 81% from $94,000. Gross profit was $10,000 versus $39,000; gross margin was approximately 56% versus 41%, but amounts were immaterial and sales were described as one-off.
  • Operating results: Operating expenses rose 192% to $17.6 million, including research and development of $8.2 million, SG&A of $8.1 million, and $1.3 million of exchange transaction expenses. Operating loss widened to $16.3 million from $4.6 million. Net loss was $17.1 million, improved from $23.1 million in 2020, when substantial convertible-note accounting charges were recorded. 2021 stock-based compensation was $6.2 million.
  • Other operating income: $1.3 million, mainly U.K. R&D tax credits ($1.1 million) and grants. The company also reported $808,000 of foreign-currency transaction losses.
  • Cash flow: Operating cash use was $10.5 million, compared with $4.1 million in 2020; investing cash use was $341,000. Financing provided $22.2 million, principally net proceeds from the February 2021 offering.
  • Liquidity and balance sheet: Cash was $12.2 million at year-end, up from $764,000. Current assets were $14.1 million and current liabilities $1.5 million. Total liabilities were $1.5 million; no debt was outstanding at year-end. Stockholders’ equity was $13.5 million and accumulated deficit was $75.1 million.
  • Financing and commitments: The February 2021 private placement generated $24.6 million gross and $22.2 million net proceeds. A $738,000 tax-credit-backed loan was repaid in March 2021. Contractual lease and purchase obligations totaled $1.5 million, primarily due in 2022–2024.

Material changes versus 2020

  • Revenue declined by $76,000, while operating expenses increased by $11.6 million. R&D expense rose 90% and SG&A rose 373%; reported drivers included stock compensation, expanded teams, public-company costs, and development and demonstration work.
  • Operating cash use increased by $6.5 million. Year-end cash increased substantially because of the 2021 equity offering.
  • Net loss narrowed despite the higher operating loss, primarily because 2020 included large noncash and accounting charges related to convertible notes that converted to equity.
  • In October 2021, SmartKem agreed with RiTdisplay to develop a full-color AMOLED demonstration display. The company also entered a Nanosys joint development agreement in February 2022, after year-end.

Outlook, risks, and unusual items

  • Management expected year-end cash to fund operations through at least the first quarter of 2023, but stated that additional capital will be needed for longer-term operations and commercialization. The auditor’s report highlights substantial doubt about the company’s ability to continue as a going concern; the financial statements include no adjustments for a possible failure to continue.
  • No quantified revenue, earnings, or product-launch guidance is provided. Management expects continued losses and significant expenses, with investment in materials, EDA tools, foundry services, sales, and public-company infrastructure.
  • Commercialization depends on customer adoption and lengthy sales cycles, estimated at 12–24 months, with significant prototype and development costs and no assurance of orders. SmartKem lacks commercial-scale fabrication capacity and relies on CPI for prototypes while seeking third-party manufacturing partners.
  • COVID-19 restrictions disrupted travel, customer engagement, and prospective customers’ manufacturing and supply chains; management cited increased shipping costs. Other disclosed risks include competition and technology change, dependence on external manufacturing, intellectual-property protection, international and currency exposure, and the need for future financing.
  • Management said prior material weaknesses in internal control were remediated by December 31, 2021 and concluded controls were effective. The auditor did not attest to internal-control effectiveness. Common-stock quotations on OTCQB began in February 2022; the filing notes that trading may be limited and volatile.
  • After year-end, the company sold 1.0 million shares to Octopus investors for $2.0 million gross proceeds on January 27, 2022. The filing also reports a 2021 equity-based compensation charge of $6.2 million and $1.3 million of exchange transaction expenses.

Key facts investors should verify

  • Whether cash burn, planned spending, and any subsequent financing support the stated runway, given the going-concern uncertainty.
  • Whether development agreements progress to paid orders, recurring revenue, or licensing, and how much revenue depends on demonstrations and grants.
  • Availability, cost, capacity, and qualification timing of commercial-scale manufacturing partners beyond CPI.
  • Current share count and potential dilution from warrants, options, equity-plan increases, and registered resale shares.
  • Progress in sustaining effective financial controls and execution of the stated remediation measures.