INTUITIVE SURGICAL INC quarterly report, Q3 FY2015

Intuitive Surgical, Inc. — Q3 2015 Form 10-Q

Reporting period: Quarter ended September 30, 2015; comparisons are with the same 2014 period unless noted. Intuitive Surgical designs, manufactures, and sells da Vinci surgical systems, instruments and accessories, and related service.

Financial performance

MetricQ3 2015Q3 2014Nine months 2015Nine months 2014
Total revenue$589.7 million$550.1 million$1,707.9 million$1,527.0 million
Gross profit / margin$395.8 million / 67%$360.6 million / 66%$1,119.1 million / 66%$1,020.4 million / 67%
Operating income / margin$189.9 million / 32%$159.1 million / 29%$494.1 million / 29%$358.7 million / 23%
Net income$167.3 million$123.7 million$398.8 million$272.0 million
Diluted EPS$4.40$3.35$10.55$7.18
Operating cash flowNot separately stated for the quarter$488.5 million$470.9 million

Q3 revenue increased 7%; recurring revenue rose 9% to $415.5 million, or 70% of revenue, while systems revenue rose 3% to $174.2 million. Nine-month revenue increased 12%, with recurring revenue up 10% and systems revenue up 17%. Q3 da Vinci procedures increased approximately 15%; nine-month procedures increased approximately 14%.

At September 30, cash and cash equivalents were $868.2 million, short-term investments $871.5 million, and long-term investments $1,385.5 million—about $3.1 billion combined. Total assets were $4,682.3 million and total liabilities $567.1 million. The balance sheet reports no interest-bearing debt. Current assets of $2,398.8 million compared with current liabilities of $478.6 million.

Nine-month investing cash outflow was $436.4 million, mainly reflecting net investment purchases and $61.3 million of property, equipment, and acquired intellectual property purchases. Financing cash inflow was $217.2 million, including employee stock-plan proceeds; the company repurchased $99.5 million of stock. The 2015 authorization had $900.5 million remaining at quarter-end.

Material changes and operating developments

  • Q3 operating income rose 19%. For the nine-month period, SG&A declined 10% to $480.2 million, largely because product-liability charges were lower than in 2014; R&D increased 11% to $144.8 million, reflecting development organization growth and project costs.
  • Q3 gross margin improved year over year, helped by lower recall-related costs than in Q3 2014 and improved manufacturing efficiency. Nine-month product margin fell to 65.6% from 67.1%, in part due to newer products and foreign-currency effects; nine-month service margin also eased, partly due to initial Xi servicing costs.
  • The installed base reached approximately 3,477 systems, up from approximately 3,266 at year-end 2014. The da Vinci Xi represented 90 of 117 Q3 system shipments. Q3 U.S. procedures grew approximately 12% and international procedures approximately 28%.
  • Revenue was adversely affected by U.S.-dollar strength. Foreign-currency revenue was approximately 19% of Q3 and nine-month revenue; hedges partially offset the currency impact.

Outlook, commentary, risks and unusual items

  • No numerical revenue, earnings, or procedure guidance is provided. Management expects continued substantial investment in commercial operations, product development, manufacturing, facilities, and procedure adoption, and expects R&D expense to continue increasing. Management believes cash, investments, and operating cash generation are sufficient for foreseeable liquidity needs.
  • Management expects international procedures and revenue to grow faster than U.S. business over time, but highlights uncertainty around China’s system-purchasing tender and future authorizations, and Japan’s reimbursement decisions for procedures beyond prostatectomy.
  • Product-liability exposure remains material: the company was defending approximately 90 individual cases and a multi-plaintiff case involving 45 patients. It recorded $13.8 million in product-liability charges in the first nine months of 2015 and reported $29.9 million accrued for tolled claims at September 30. The ultimate cost could materially exceed the estimate; excess loss could not be estimated.
  • Other risks include adoption and reimbursement trends, competition, regulatory clearances and field actions, negative publicity, foreign exchange, and hospital spending. The company reported a prior Stapler 45 recall and a 2015 safety notice concerning certain equipment drapes; replacement drape supply was still being addressed.
  • Tax results included a $29.3 million benefit related to a U.S. Tax Court opinion and approximately $7.8 million of discrete benefits from tax-audit resolutions. The nine-month effective tax rate was 21.3%, versus 25.3% in 2014. Gross unrecognized tax benefits were approximately $83.5 million.
  • The FDA conducted a routine Sunnyvale inspection in October 2015, after quarter-end; no observations were communicated at its close, and the final inspection report was expected in Q4 2015.

Investor verification priorities

  • Assess whether procedure growth and recurring revenue can continue to support growth as system shipments, procedure mix, and foreign exchange fluctuate.
  • Review the product-liability accrual, settlement progress, insurance disputes, and potential exposure beyond recorded amounts.
  • Track Xi product margins and service costs as manufacturing and repair programs mature.
  • Verify developments in China’s tender process, Japan reimbursement, regulatory clearances, and product field actions.
  • Separate underlying earnings performance from the 2015 tax benefits and compare cash generation with share-based compensation and stock repurchases.