ICU MEDICAL INC quarterly report, Q1 FY2009

ICU Medical, Inc. — Q1 2009 Form 10-Q

Business context and period: The company develops, manufactures, and sells disposable medical devices, including needleless connectors, custom infusion sets, and critical-care products. This unaudited report covers the three months ended March 31, 2009; comparisons are with Q1 2008 unless otherwise stated. Amounts below are in U.S. dollars.

Financial performance

MetricQ1 2009Q1 2008
Total revenue$54.3 million$44.7 million
Gross profit / margin$26.6 million / 48.9%$17.8 million / 39.8%
Operating income / margin$10.7 million / 19.7%$2.6 million / 5.9%
Net income$7.1 million$2.9 million
Diluted earnings per share$0.47$0.20
Cash provided by operating activities$19.8 million$4.7 million

Revenue mix and drivers: Net sales rose 24% to $54.2 million; total revenue increased about 22%. CLAVE sales rose 16% to $21.2 million, custom products increased to $19.0 million from $14.9 million, and critical-care sales grew to $9.6 million from $7.4 million. Oncology product sales, including custom oncology, were $4.3 million versus $1.3 million. Other revenue fell to $0.1 million from $1.0 million because a 2008 exclusivity payment did not recur.

Gross margin improved from 40% to 49%, which management attributed to product mix, improved Mexico manufacturing efficiency, favorable currency movements on costs, and lower transportation costs. SG&A increased to $15.1 million from $13.1 million, mainly due to higher patent-litigation costs, compensation, and sales and marketing. R&D declined to $0.7 million from $2.0 million, primarily reflecting a narrower focus on core projects and MedScanSonics ceasing operations in 2008. Other income decreased to $0.3 million from $1.6 million, including because of lower interest income and the nonrecurrence of a settlement payment.

Financial position and liquidity

  • At March 31, 2009, cash and cash equivalents were $68.0 million; current and noncurrent investment securities totaled $73.8 million. Combined cash, cash equivalents, and investment securities were $141.9 million, up from $123.1 million at year-end 2008.
  • Current assets were $193.2 million and current liabilities were $23.1 million. The balance sheet reports no borrowings or other debt.
  • Operating cash flow was $19.8 million. Investing activities used $8.2 million, including $5.7 million for the German acquisition and $2.1 million for property and equipment. Financing activities provided $1.3 million. Cash and cash equivalents increased by $12.3 million during the quarter.
  • Inventory increased to $21.7 million from $17.9 million; accounts receivable declined to $30.3 million from $38.4 million. Management said the receivables decrease primarily reflected collections on Q4 2008 sales.
  • Management stated that available cash, investments, and expected operating cash flows should fund operations for at least the next 12 months. It estimated 2009 capital expenditures of approximately $15 million, including about $4 million for land and initial construction of a custom-products plant in Slovakia.

Material changes, outlook, and risks

  • Customer concentration: Hospira accounted for 71% of Q1 2009 revenue, up from 66% in Q1 2008, and 62% of accounts receivable at quarter-end. The company depends on Hospira agreements and has limited influence over Hospira’s marketing and sales of certain products.
  • Acquisition: ICU Medical acquired a small Germany-based manufacturing and distribution company in February 2009 for approximately $5.7 million. It contributed about $0.7 million of Q1 sales. The acquisition added oncology and neonatal products and $6.1 million of intangible assets, including $1.9 million of goodwill.
  • Management estimates: The company expected 2009 gross margin of 44%–45%, SG&A of 27%–28% of revenue, R&D of 1%–2% of revenue, and an effective tax rate of about 36%. It anticipated growth in CLAVE, custom infusion, oncology, and international sales, with potential declines in critical-care and custom critical-care volumes. These are forward-looking estimates, not guarantees.
  • Market and operating risks: Management said the challenging economy had not meaningfully affected reported results, but some customers began taking a more conservative approach to inventory near quarter-end. Other risks include seasonal and customer-order fluctuations, competition and price pressure, product-development and acquisition execution, and reliance on Hospira. The filing added risks associated with growing dependence on Mexico manufacturing, including cross-border disruptions, labor availability and costs, and personnel safety concerns.
  • Investments: The portfolio included $11.7 million of auction-rate securities and $0.4 million of related put-option assets. Auctions had failed since February 2008, impairing liquidity; agreements with Morgan Stanley and UBS gave the company rights to require purchases at par plus accrued interest. The company reported less than $0.1 million of market-value declines in these securities during Q1.
  • Legal contingencies: Medegen’s patent case was remanded to the district court after an appellate reversal; the company intends to defend the claim and recorded no accrual because the outcome was uncertain. In the Alaris patent litigation, a $5.0 million fee-and-cost judgment had been recorded in 2007; the company had not paid it pending the outcome of its rehearing petition. RyMed patent and related claims were also pending.
  • The company reported no material change in internal control over financial reporting and concluded its disclosure controls were effective. Interim results are not necessarily indicative of full-year results.

Important facts for investors to verify

  • Whether Hospira’s concentration and customer ordering patterns remain stable, and how the long-term Hospira agreements affect future sales and margins.
  • Whether the Q1 gross-margin improvement is sustainable against management’s 44%–45% full-year estimate.
  • Progress integrating the German acquisition and executing the Slovakia plant and other planned capital expenditures.
  • Liquidity and valuation of auction-rate securities, including enforceability and timing of the put arrangements.
  • Developments in the Medegen, Alaris, and RyMed litigation, including any resulting costs or liabilities.
  • Whether Mexico-related labor, security, and cross-border risks affect manufacturing continuity or costs.