BOSTON SCIENTIFIC CORP annual report, FY2009

Boston Scientific Corporation — FY 2009 Form 10-K

Reporting period: Year ended December 31, 2009. The filing also reports fourth-quarter results; this is an annual report, not a standalone Q4 filing. All amounts are U.S. dollars.

Business context

Boston Scientific develops and sells less-invasive medical devices across cardiac rhythm management (CRM), cardiovascular, neurovascular, endoscopy, urology and women’s health, and neuromodulation. International markets generated approximately 43% of 2009 sales. The company reported approximately $8.2 billion in annual sales.

Financial results and liquidity

MetricFY 2009FY 2008
Net sales$8.188 billion$8.050 billion
Gross profit / margin$5.612 billion / 68.5%$5.581 billion / 69.3%
Operating income (loss)$(894) million$(1.505) billion
Net income (loss)$(1.025) billion$(2.036) billion
Diluted loss per share$(0.68)$(1.36)
Cash from operations$835 million$1.216 billion
Capital expenditures$312 million$362 million
Cash and cash equivalents$864 million$1.641 billion
Total debt$5.918 billion$6.745 billion
Working capital$1.039 billion$2.219 billion

Sales rose 2% as reported. Excluding currency effects and sales from divested businesses, management reported 4% growth. Foreign exchange reduced 2009 sales by $92 million. Gross margin declined, principally from a shift in drug-eluting stent sales from higher-margin TAXUS products toward Abbott-supplied PROMUS products. Operating loss included substantial litigation, restructuring and impairment-related items; the 2009 net loss included $1.785 billion of specified items after tax, according to management.

Operating cash flow fell by $381 million, with litigation payments a major factor; the company cites $823 million of litigation-related payments in its cash-flow discussion. Net debt was $5.054 billion at year-end, compared with $5.104 billion in 2008. The company issued $2.0 billion of senior notes and prepaid its remaining $2.825 billion term loan during 2009. Its revolving-credit covenants were met at year-end. Working capital declined materially; current assets were $4.061 billion and current liabilities $3.022 billion.

Changes versus prior year and Q4

  • CRM sales increased 5% to $2.562 billion; neuromodulation rose 17% to $285 million, endoscopy rose 7% to $1.006 billion, and urology/women’s health rose 6% to $456 million.
  • Cardiovascular group sales declined 1% to $3.520 billion; neurovascular sales declined 3% to $348 million. Interventional cardiology sales excluding coronary stents fell 5% to $980 million.
  • Coronary stent sales increased 2% to $1.879 billion, but U.S. drug-eluting-stent average selling prices fell approximately 8%. Abbott-supplied PROMUS products accounted for approximately 40% of drug-eluting-stent sales and had substantially lower margins than TAXUS.
  • FY net loss improved from 2008, when the company recorded a $2.613 billion goodwill impairment charge. However, 2009 included $2.022 billion of litigation-related net charges, primarily associated with Johnson & Johnson matters and a U.S. Department of Justice agreement in principle.
  • In Q4 2009, sales were $2.079 billion, gross profit $1.369 billion, operating loss $1.231 billion, net loss $1.075 billion, and diluted loss per share $0.71. The large quarterly loss reflected significant litigation-related charges.

Outlook, management commentary and material risks

  • Restructuring: A 2010 plan announced after year-end is expected to eliminate 1,000–1,300 positions by the end of 2011, incur $180–$200 million of pre-tax charges, and reduce pre-tax operating expenses by approximately $200–$250 million when completed. Management expects the plant-network program to reduce annual manufacturing costs by $65–$80 million in 2012, in addition to $35–$40 million from the 2007 restructuring plan.
  • Investment and spending: R&D expense was $1.035 billion, about 12.6% of sales. Planned 2010 capital expenditures were approximately $350–$400 million. The company cited launches of next-generation CRM, stent, neurovascular and other products, subject to approvals and execution.
  • Debt and settlement obligations: A January 2010 settlement with Johnson & Johnson requires $1.725 billion plus interest. Boston Scientific paid $1.0 billion in February 2010, including $200 million drawn under its revolver, and must pay the balance by January 3, 2011. It also expected to refinance most 2011 debt maturities and its revolving facility by mid-2010; $1.750 billion of debt and the facility were due in 2011.
  • Legal and regulatory exposure: The company recorded a $296 million charge for an agreement in principle with DOJ concerning Guidant product advisories; it expected payment in 2010 and entered a Corporate Integrity Agreement. The FDA had removed site restrictions after reinspections, but the corporate warning letter remained pending administrative procedures. Other patent, product-liability, securities and government matters remain.
  • Business risks: Key exposures include competitive and pricing pressure, clinical-trial results and physician confidence, reimbursement and healthcare reform, product approvals and recalls, reliance on Abbott for certain U.S. and Japanese stent supply through mid-2012, supplier and sterilization continuity, foreign currency, and execution of restructuring. Two reporting units, U.S. CRM and EMEA, held approximately $7.4 billion of goodwill and were identified as having elevated impairment risk in future periods, although the 2009 annual test found no impairment.
  • Other: No cash dividends were paid in 2009, 2008 or 2007, and none were then intended. Management reported effective disclosure controls and internal control over financial reporting; the auditor gave unqualified opinions on the financial statements and internal controls.

Important facts for investors to verify

  • Reconcile the $2.022 billion litigation charge and $2.316 billion year-end legal accrual with settlement payments, remaining obligations and other legal matters.
  • Confirm completion and terms of the planned refinancing of 2011 maturities and the effect of settlement payments and the $745 million letter of credit on available liquidity.
  • Track realized savings, cash restructuring costs and operational effects against management’s 2010 restructuring and plant-network estimates.
  • Monitor CRM and stent sales, price trends, product launches and approvals, Abbott supply arrangements, and resulting gross-margin performance.
  • Assess goodwill impairment sensitivity in U.S. CRM and EMEA and review developments in FDA, DOJ, product-liability and patent proceedings.