Business Context and Reporting Period
Company: Amedica Corporation (Note: Request metadata listed "Sintx Technologies," but the filing text identifies the registrant as Amedica Corporation).
Reporting Period: Quarterly Report (Form 10-Q) for the period ended September 30, 2017.
Business Overview: Amedica is a materials company focused on developing, manufacturing, and selling silicon nitride ceramics for medical implants, primarily in the spine market. The company operates as a smaller reporting company and is the only vertically integrated silicon nitride medical device manufacturer.
Key Financial Metrics
| Metric | Three Months Ended Sep 30, 2017 | Nine Months Ended Sep 30, 2017 | As of Sep 30, 2017 |
|---|---|---|---|
| Product Revenue | $2.96 million | $8.79 million | - |
| Gross Profit | $1.55 million (52% margin) | $6.00 million (68% margin) | - |
| Net Loss | $(2.82) million | $(7.07) million | - |
| Cash and Equivalents | - | - | $2.82 million |
| Total Debt (Current) | - | - | $4.61 million |
| Accumulated Deficit | - | - | $(220.21) million |
| Operating Cash Flow | - | $(4.40) million used | - |
Material Changes vs. Prior Period
- Revenue Decline: Product revenue decreased 12% ($0.42 million) for the quarter and 24% ($2.78 million) for the nine months compared to the prior year periods. This was primarily attributed to the loss of surgeons and the aftermath of restructuring efforts in late 2016.
- Gross Margin Compression: Gross profit margin dropped from 77% to 52% for the quarter and from 77% to 68% for the nine months. This decline was driven by a significant increase in the provision for inventory reserves ($0.9 million for the quarter; $0.4 million for the nine months).
- Expense Reductions: Total operating expenses decreased 29% year-over-year for both the quarter and nine-month periods due to workforce reductions and cost-saving measures implemented in 2016.
- Net Loss Improvement: Despite revenue declines, the net loss narrowed by 35% for the quarter and 45% for the nine months, largely due to reduced interest expense and the absence of debt extinguishment costs seen in the prior year.
Outlook, Risks, and Management Commentary
- Liquidity and Going Concern: The filing includes a "Going Concern" warning. The company has an accumulated deficit of $220 million and expects to continue generating operating losses. Continuation as a going concern is dependent on raising additional funds and maintaining debt covenant compliance.
- Debt Covenants: The company has a liquidity covenant with its Hercules Term Loan requiring a minimum cash balance of $2.5 million. As of September 30, 2017, cash was $2.82 million. Management believes it can maintain compliance through November 2017 but may require additional financing thereafter.
- Recent Financing: In July 2017, the company secured a $2.5 million term loan from a related party (North Stadium Investments, LLC, controlled by the CEO) to assist with cash needs. In the nine months ended September 30, 2017, the company also raised approximately $3.8 million via a secondary offering of common stock.
- Strategic Focus: Management is focusing on revenue growth for silicon nitride lateral lumbar implants and a new pedicle screw system (Taurus). They are also generating clinical data to support sales efforts.
- Internal Controls: Management concluded that disclosure controls and procedures were not effective as of September 30, 2017, due to material weaknesses in accounting for complex transactions and lack of qualified personnel following the dismissal of the CFO.
- Reverse Stock Split: A 1-for-12 reverse stock split was effected on November 10, 2017. Historical share data in the filing has been adjusted retroactively.
Investor Verification Checklist
- Cash Runway: Verify if the company has secured financing beyond November 2017 to avoid default on the Hercules Term Loan liquidity covenant.
- Inventory Valuation: Review the justification for the increased inventory reserve provisions, which significantly impacted gross margins.
- Related Party Transactions: Assess the terms and risks associated with the $2.5 million loan from the CEO-controlled entity.
- Internal Control Remediation: Monitor progress on fixing material weaknesses in financial reporting controls to prevent future restatements.
- Revenue Trends: Confirm if the decline in surgeon adoption is stabilizing or if the new product launches (Taurus) are gaining traction.