GT Biopharma, Inc. annual report, FY2011

Business context and reporting period

Issuer discrepancy: The filing is for OXIS International, Inc., not GT Biopharma, Inc. It is a Form 10-K for the fiscal year ended December 31, 2011, filed April 16, 2012; it reports annual results, not a standalone 2011 fourth quarter.

OXIS had shifted from diagnostic products to developing and selling nutraceutical and personal-care products, primarily using its proprietary ergothioneine ingredient, EGT. ErgoFlex, its joint-health supplement, was test-marketed; commercial operations remained very limited.

Financial results and position

Metric20112010
Revenue$26,000$11,000
Cost of product revenue$48,000$65,000
Gross loss$22,000$54,000
Operating expenses$3.906 million$2.443 million
Operating loss$3.928 million$2.497 million
Net loss$3.700 million$2.995 million
Cash used in operations$963,000$1.535 million
Cash and cash equivalents at year-end$92,000$54,000
Working capitalDeficit of $5.126 millionNot clearly stated in the supplied text

Revenue rose 136% from a very low base, but OXIS said it had no further sales after its test marketing because it lacked funding to launch the online sales effort. Gross margin remained negative. Management estimated future commercial-product gross margins above 50%, but this was a forecast, not a reported result.

Current liabilities were $5.230 million, including accrued interest of $1.598 million, convertible debentures of $1.770 million in total, demand notes of $266,000, and warrant liability of $158,000. The balance sheet reported a stockholders’ deficit of $5.101 million and an accumulated deficit of $83.795 million. Cash from financing activities was $1.001 million in 2011. The company reported no off-balance-sheet arrangements.

Material changes versus the prior comparable period

  • Net loss increased to $3.700 million from $2.995 million; the filing separately reports 2010 net loss attributable to common shareholders of $3.018 million after deemed dividends.
  • SG&A rose $1.205 million to $3.469 million, primarily due to non-cash stock compensation, including approximately $2.4 million in executive stock-based compensation described in MD&A.
  • Research and development expense fell to $17,000 from $179,000. Cash used in operations declined to $963,000 from $1.535 million.
  • Common shares outstanding increased from 149.6 million at December 31, 2010 to 269.3 million at December 31, 2011, largely through debt conversions and shares issued for services.

Outlook, risks and unusual items

Management planned to launch ErgoFlex online through a joint venture with engage:BDR by the end of April 2012 and expected additional EGT-based products, including skin-care products. OXIS agreed to contribute up to $240,000 to the venture; excess operating cash would first repay OXIS’s contributions and then be distributed 50.1% to OXIS and 49.9% to engage:BDR. The filing described a further $1 million investor funding commitment, with amounts funded reported inconsistently in different sections; OXIS also stated that it had received $495,000 as of March 31, 2012.

The independent auditor and management cited substantial doubt about the company’s ability to continue as a going concern. Management said year-end cash was sufficient for only a few months of administrative expenses and that additional financing would be needed; there was no assurance it could be obtained or that product sales would meet cash needs. The company had $995,000 outstanding on Bristol demand notes and a history of defaults on older secured debentures. New debt and equity financing could add repayment obligations and dilute shareholders.

Other material risks include dependence on the online joint venture and third-party manufacturers, uncertain consumer acceptance, competition, product liability, regulatory limits on supplement and advertising claims, and uncertain patent protection. The filing states disclosure controls and internal control over financial reporting were ineffective at year-end, citing inadequate segregation of duties and risk of executive override. Dilution is substantial: as of March 31, 2012, the company disclosed 300.3 million common shares outstanding and 417.8 million additional shares potentially issuable under options, warrants, convertible notes and other agreements. Series H preferred stock held by Theorem Group carried voting power equivalent to 250 million common shares, approximately 45.4% of voting shares as reported.

Unusual items include a $784,000 gain from changes in warrant and derivative liability values, which partly offset operating losses, and significant stock-based compensation. The financial statements received an unmodified audit opinion, but the auditor highlighted going-concern uncertainty and did not express an opinion on internal-control effectiveness.

Important facts for investors to verify

  • Confirm the issuer identity: the supplied filing names OXIS International, Inc., despite the request metadata naming GT Biopharma, Inc.
  • Reconcile the $1 million funding commitment and the different reported funded amounts, and confirm the status and terms of subsequent financing.
  • Verify actual post-filing product launch timing, sales, margins, joint-venture performance, and cash requirements against management’s 2012 expectations.
  • Review debt maturity, default and forbearance terms, accrued interest, and potential consequences if additional financing is unavailable.
  • Assess fully diluted share exposure, including convertible securities, warrants, options, and the voting rights of Series H preferred stock.
  • Review remediation of the disclosed material weaknesses in financial reporting controls and the company’s ongoing liquidity and going-concern status.