GT Biopharma, Inc. annual report, FY2013

Filing identity and reporting period

The supplied document is OXIS International, Inc.’s Form 10-K for the fiscal year ended December 31, 2013, filed January 8, 2015. It is not identified as a GT Biopharma, Inc. filing; verify the issuer before relying on this summary.

OXIS focused on products related to oxidative stress, especially ergothioneine (ERGO/EGT), including nutraceutical and skin-care products, and potential licensing of proprietary compounds. It reported limited operations and revenue. The filing also describes a planned cannabinoid therapeutics business through subsidiary Oxis Biotech, formed in September 2014.

Financial performance and position

Metric20132012
Revenue$368,000$342,000
Cost of product revenue$226,000$94,000
Gross profit and margin$142,000; 38.6%$248,000; 72.5%
Operating expenses$935,000$3,762,000
Operating loss$(793,000)$(3,514,000)
Net loss$(501,000)$(5,171,000)
Net cash used in operating activities$(442,000)$(987,000)
Cash and cash equivalents at year-end$43,000$123,000
Total assets$147,000$226,000
Total liabilities$6,481,000$6,562,000

At year-end 2013, current assets were $125,000, current liabilities were $6,384,000, and the working-capital deficit was $6,259,000. Accumulated deficit was $89,467,000. Interest expense was $1,196,000, versus $1,653,000 in 2012. The filing does not provide a clear standalone EBITDA or operating-margin measure.

Material changes versus 2012

  • Revenue rose 7.6%, but cost of product revenue increased substantially, reducing gross profit by $106,000 and gross margin from approximately 72.5% to 38.6%.
  • Selling, general and administrative expense fell by $2,427,000, primarily due to lower stock-based compensation, advertising and consulting costs. Research and development expense was zero in both years.
  • Net loss improved by $4,670,000. A $1,425,000 gain from changes in the fair value of warrant and derivative liabilities, compared with a $94,000 expense in 2012, materially affected the comparison; this was not operating revenue.
  • Operating cash use declined, but cash fell by $80,000 during 2013. Financing activities provided $425,000 net, chiefly through notes payable.
  • Common shares outstanding increased from approximately 500.6 million to 573.1 million. At year-end, the company also had approximately 591.0 million warrants outstanding.

Outlook, risks and unusual items

  • Going concern: The auditor and management cited substantial doubt about OXIS’s ability to continue as a going concern, given recurring losses, minimal cash and dependence on additional financing. The statements contain no adjustments for a possible inability to continue operations.
  • Funding and liquidity: Management said year-end cash would cover administrative expenses for the next 12 months, but also said expenses could approach $5 million annually if the Oxis Biotech strategy advanced and that it would seek $5 million in funding in Q1 2015. Neither financing nor business-plan execution was assured.
  • Debt and dilution: The company relied on convertible debentures and demand notes, including 2013 instruments with 10% interest and conversion prices as low as $0.007 per share, alongside warrants. These financing terms create potential dilution. Certain legacy debt was secured by substantially all assets; the filing describes defaults and unpaid obligations on older debentures.
  • Controls and governance: Management concluded disclosure controls and internal control over financial reporting were ineffective at December 31, 2013 and identified material weaknesses, including inadequate segregation of duties and risk of executive override. A new CFO was hired in November 2014. None of the three directors was considered independent, and the board performed committee functions as a whole.
  • Commercial and regulatory execution: Product plans depended on outsourced manufacturing, marketing and distribution. Consumer health claims and products are subject to FDA, FTC and other regulation; the filing notes that claims may be restricted and compliance can add cost. OXIS had two employees as of December 2014.
  • Business development and legal matter: The ERGO skin-care business had limited sales, and planned products and cannabinoid drug candidates remained development-stage initiatives. A 2014 licensing dispute was resolved for a cash payment and perpetual royalty on future product sales; amounts were not stated in the supplied text.
  • The filing states that it qualifies as a smaller reporting company and therefore omits the Item 1A risk-factor disclosure.

Key facts for investors to verify

  1. Confirm the issuer: the filing and financial statements are for OXIS International, Inc., notwithstanding the request metadata naming GT Biopharma, Inc.
  2. Review the audited statements and notes for current debt balances, defaults, collateral rights, conversion terms, and subsequent financings; the filing reports only $43,000 of cash against a $6.259 million working-capital deficit at year-end.
  3. Assess the scale of potential dilution from convertible securities, warrants, options and later share issuances, and reconcile those instruments with the reported share counts.
  4. Check whether the proposed $5 million financing and Oxis Biotech plans were completed, and whether subsequent operations generated revenue or required additional capital.
  5. Evaluate remediation of the disclosed material weaknesses and whether later filings report improved controls, independent governance and adequate financial reporting.