KORU Medical Systems, Inc. quarterly report, Q1 FY2016

KORU Medical Systems, Inc. (filed as Repro Med Systems, Inc.) — Form 10-Q Summary

Business context and reporting period

The filing covers the quarter ended May 31, 2015, compared with the quarter ended May 31, 2014. The company designs, manufactures, and markets medical devices, including the FREEDOM60 infusion system, HIgH-Flo safety needle sets, and RES-Q-VAC portable suction products. It reports one operating segment.

Financial performance and liquidity

MetricQuarter ended May 31, 2015Comparable 2014 period
Net sales$2.631 million$2.637 million
Gross profit / gross margin$1.518 million / 57.7%$1.526 million / 57.9%
Operating expenses$1.597 million$1.285 million
Operating income (loss)$(78,864)$241,099
Net income (loss)$(64,640)$158,056
Operating cash flow$11,101$265,690
Investing cash flow$(97,700)$(154,340)

At May 31, cash and cash equivalents were $2.471 million, with certificates of deposit of $260,000. Current assets were $6.027 million and current liabilities $904,000. Total liabilities were $1.212 million; the balance sheet reports no conventional debt, and financing cash flows were zero. Cash declined $86,599 during the quarter to $2.471 million. The filing presents basic and diluted earnings per share as dashes, so a clear per-share value is not provided.

Material changes versus the prior period

  • Sales were nearly flat overall. Domestic sales decreased 9.4% to $2.009 million, which management attributed largely to a clinical-trial order in the prior-year quarter; international sales rose 47.8% to $621,471.
  • Gross margin edged down 0.2 percentage points. Management attributed the decline mainly to consulting fees for lean-manufacturing initiatives.
  • Selling, general and administrative expense rose 35.1% to $1.478 million, including approximately $200,000 in severance and $200,000 in recruiting and consulting fees associated with a reorganization.
  • Research and development expense fell 59.2% to $53,665, primarily due to reduced outside consulting and departmental attrition.
  • Net results swung from income to loss, mainly reflecting higher SG&A. A foreign-exchange loss of $15,070 and a $4,606 loss on disposal of fixed assets also affected the quarter.
  • Operating cash flow fell to $11,101 from $265,690; inventory and prepaid expenses increased, partly offset by lower receivables and higher payables and accrued payroll.

Outlook, risks, contingencies, and unusual items

Management said cash on hand and expected operating cash generation should fund operations, R&D, and capital expenditures for the next 12 months. It expects lean-manufacturing improvements to begin benefiting gross margins in fiscal 2016’s second quarter. The company introduced the FreedomEdge pump in March 2015 and had begun shipping it for evaluation; no quantified sales or earnings guidance was provided.

Management cited risks including FDA and other regulatory requirements, competition, reimbursement and home-health-care regulation, product acceptance and market expansion, R&D success, patent protection, capital availability, and dependence on key personnel. A competitor patent dispute remained ongoing: a June 16, 2015 preliminary injunction restricts certain company statements, and the competitor filed a separate patent-infringement claim in Texas on June 25, 2015. The company said it was complying with the injunction and believed the claims were without merit; it had not yet answered the Texas complaint.

Related-party matters include a director’s three-year stock-compensation arrangement for clinical research and support, and an aircraft lease from a company controlled by the president; the lease was month-to-month after expiration of the original agreement. No material subsequent events through July 10, 2015 were reported. Management stated disclosure controls were effective and reported no material change in internal control over financial reporting during the quarter.

Important facts for investors to verify

  • Whether sales growth in international markets can offset domestic weakness and support sustained overall growth.
  • Whether the reorganization and lean-manufacturing initiatives deliver the anticipated cost savings and margin improvement.
  • FreedomEdge evaluation-to-commercial conversion, and the actual contribution of newer products to revenue.
  • Cash generation and working-capital trends, especially inventory and prepaid expense growth, against management’s 12-month liquidity assessment.
  • Developments, potential costs, and business effects of the competitor litigation and preliminary injunction.
  • The filing reports 38,006,667 common shares outstanding as of July 10, 2015, excluding 2,340,625 treasury shares; investors may wish to verify subsequent share-count changes.