UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
QUARTERLY REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT
OF 1934
For the quarterly period ended June 30, 2004
Commission File Number 1-13388
GUIDANT CORPORATION
(Exact name of
Registrant as specified in its charter)
INDIANA (State or other jurisdiction of incorporation or organization) |
35-1931722 (I.R.S. Employer Identification No.) |
111 MONUMENT CIRCLE, 29TH FLOOR
INDIANAPOLIS, INDIANA 46204-5129
(Address of principal
executive offices)
Registrants telephone number, including area code: (317) 971-2000
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes X No _____
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
Yes X No _____
The number of shares of common stock outstanding as of August 4, 2004:
Class | Number of Shares Outstanding | ||
Common | 314,576,547 |
GUIDANT CORPORATION
Consolidated
Statements of Operation
(In millions, except
per share data)
(unaudited)
Three Months Ended June 30, |
Six Months Ended June 30, | ||||||||
---|---|---|---|---|---|---|---|---|---|
2004 | 2003 | 2004 | 2003 | ||||||
Net sales | $ 938.8 | $ 926.6 | $ 1,872.9 | $ 1,784.5 | |||||
Cost of products sold | 234.6 | 224.5 | 460.9 | 429.6 | |||||
Gross profit | 704.2 | 702.1 | 1,412.0 | 1,354.9 | |||||
Research and development | 136.8 | 129.4 | 274.4 | 242.2 | |||||
Purchased in-process research and development | 73.0 | 12.0 | 99.8 | 48.5 | |||||
Sales, marketing and administrative | 298.1 | 297.2 | 612.8 | 566.2 | |||||
Interest, net | (0.2) | (2.5) | (1.2) | (3.9) | |||||
Royalties, net | 12.5 | 15.7 | 24.6 | 29.0 | |||||
Amortization | 7.7 | 3.3 | 15.0 | 6.5 | |||||
Other, net | 6.4 | 0.4 | 8.9 | 5.7 | |||||
Litigation, net | -- | 422.8 | -- | 422.8 | |||||
Income (loss) from continuing operations before income taxes | 169.9 | (176.2) | 377.7 | 37.9 | |||||
Income taxes | 34.3 | (94.4) | 89.1 | (36.7) | |||||
Income (loss) from continuing operations | 135.6 | (81.8) | 288.6 | 74.6 | |||||
Loss from discontinued operations, net of income taxes | (9.1) | (15.3) | (22.7) | (78.3) | |||||
Net income (loss) | $ 126.5 | ($ 97.1) | $ 265.9 | ($ 3.7) | |||||
Earnings (loss) per share-basic | |||||||||
Income (loss) from continuing operations | $ 0.44 | ($ 0.27) | $ 0.93 | $ 0.25 | |||||
Loss from discontinued operations, net of income taxes | (0.03) | (0.05) | (0.07) | (0.26) | |||||
Net income (loss) | $ 0.41 | ($ 0.32) | $ 0.86 | ($ 0.01) | |||||
Earnings (loss) per share-diluted | |||||||||
Income (loss) from continuing operations | $ 0.42 | ($ 0.27) | $ 0.90 | $ 0.24 | |||||
Loss from discontinued operations, net of income taxes | (0.03) | (0.05) | (0.07) | (0.25) | |||||
Net income (loss) | $ 0.39 | ($ 0.32) | $ 0.83 | ($ 0.01) | |||||
Dividends declared per common share | $ 0.10 | -- | $ 0.20 | $ 0.08 | |||||
See notes to consolidated financial statements
GUIDANT CORPORATION
Consolidated Balance
Sheets
(In millions, except
share data)
June 30, 2004 (unaudited) |
December 31, 2003 | ||||
---|---|---|---|---|---|
Assets | |||||
Current Assets | |||||
Cash and cash equivalents | $1,690.4 | $1,468.2 | |||
Short-term investments | 100.6 | -- | |||
Accounts receivable, net of allowances | |||||
of $23.5 (2004) and $24.0 (2003) | 826.9 | 822.9 | |||
Inventories | 398.0 | 401.9 | |||
Deferred income taxes | 289.0 | 313.2 | |||
Prepaid expenses and other current assets | 57.8 | 57.7 | |||
Current assets of discontinued operations | 3.6 | 16.0 | |||
Total Current Assets | 3,366.3 | 3,079.9 | |||
Other Assets | |||||
Goodwill, net of allowances of $157.9 (2004) and $157.9 (2003) | 513.3 | 512.9 | |||
Other intangible assets, net of allowances of $91.1 (2004) and | |||||
$81.7 (2003) | 179.7 | 160.8 | |||
Deferred income taxes | 9.9 | 0.9 | |||
Investments | 69.6 | 55.1 | |||
Sundry | 65.7 | 60.9 | |||
Other assets of discontinued operations | 0.3 | 20.5 | |||
Total Other Assets | 838.5 | 811.1 | |||
Property and equipment, net of accumulated depreciation of | |||||
$715.9 (2004) and $657.0 (2003) | 791.8 | 749.1 | |||
Total Assets | $4,996.6 | $4,640.1 | |||
See notes to consolidated financial statements
GUIDANT CORPORATION
Consolidated Balance
Sheets
(In millions, except
share data)
Liabilities and Shareholders' Equity | June 30, 2004 |
December 31, 2003 | |||
---|---|---|---|---|---|
(unaudited) | |||||
Current Liabilities | |||||
Accounts payable | $ 57.0 | $ 85.7 | |||
Employee compensation | 140.4 | 198.7 | |||
Other liabilities | 308.2 | 306.9 | |||
Income taxes payable | 203.9 | 197.2 | |||
Short-term debt | 250.0 | 250.0 | |||
Current liabilities of discontinued operations | 25.4 | 23.9 | |||
Total Current Liabilities | 984.9 | 1,062.4 | |||
Noncurrent Liabilities | |||||
Long-term debt | 704.1 | 698.3 | |||
Other | 156.6 | 166.1 | |||
Total Noncurrent Liabilities | 860.7 | 864.4 | |||
Commitments and contingencies | -- | -- | |||
Shareholders' Equity | |||||
Preferred stock: | |||||
Authorized shares: 50,000,000 | |||||
Issued shares: none | -- | -- | |||
Common stock, no par value: | |||||
Authorized shares: 1,000,000,000 | |||||
Issued shares: 314,844,000 (2004) | |||||
312,129,000 (2003) | 384.3 | 301.5 | |||
Additional paid-in capital | 252.3 | 242.4 | |||
Retained earnings | 2,462.5 | 2,258.9 | |||
Deferred cost, ESOP | (14.7 | ) | (17.1 | ) | |
Unearned compensation | (50.8 | ) | (25.2 | ) | |
Treasury stock, at cost: | |||||
Shares: 3,158,000 (2003) | -- | (171.2 | ) | ||
Accumulated other comprehensive income | 117.4 | 124.0 | |||
Total Shareholders' Equity | 3,151.0 | 2,713.3 | |||
Total Liabilities and Shareholders' Equity | $ 4,996.6 | $ 4,640.1 | |||
See notes to consolidated financial statements
GUIDANT CORPORATION
Consolidated
Statements of Cash Flows
(In millions)
(unaudited)
Six Months Ended June 30, | |||||
---|---|---|---|---|---|
2004 | 2003 | ||||
Operating Activities | |||||
Net income (loss) | $ 265.9 | ($ 3.7 | ) | ||
Adjustments to Reconcile Net Income (Loss) to Cash | |||||
Provided by Operating Activities | |||||
Depreciation | 69.0 | 63.0 | |||
Amortization of other intangible assets | 15.0 | 6.7 | |||
Provision for inventory and accounts receivable | 13.2 | 29.6 | |||
Purchased in-process research and development | 99.8 | 48.5 | |||
Deferred income taxes | 2.9 | (16.4 | ) | ||
Compensation earned under restricted stock and ESOP | 44.0 | 46.9 | |||
Other noncash, net | 27.8 | (46.6 | ) | ||
537.6 | 128.0 | ||||
Changes in Operating Assets and Liabilities | |||||
Receivables | (15.9 | ) | (37.8 | ) | |
Inventories | (12.9 | ) | (46.9 | ) | |
Prepaid expenses and other current assets | (9.9 | ) | 7.7 | ||
Accounts payable and accrued liabilities | (80.6 | ) | (18.0 | ) | |
Income taxes payable | 80.5 | (124.5 | ) | ||
Other liabilities | (3.3 | ) | 335.0 | ||
Net Cash Provided by Operating Activities | 495.5 | 243.5 | |||
Investing Activities | |||||
Additions of property and equipment, net | (114.6 | ) | (125.4 | ) | |
Acquisitions, net of cash acquired | (99.7 | ) | (104.8 | ) | |
Purchases of equity and short-term investments | (122.8 | ) | (0.5 | ) | |
Net Cash Used for Investing Activities | (337.1 | ) | (230.7 | ) | |
Financing Activities | |||||
Increase in borrowings, net | 6.1 | 62.2 | |||
Issuance of common stock under stock plans and other capital | |||||
transactions | 251.1 | 42.9 | |||
Dividends paid | (62.2 | ) | (24.6 | ) | |
Repurchase of common stock | (127.5 | ) | (0.3 | ) | |
Net Cash Provided by Financing Activities | 67.5 | 80.2 | |||
Effect of Exchange Rate Changes on Cash | (3.7 | ) | 82.6 | ||
Net Increase in Cash and Cash Equivalents | 222.2 | 175.6 | |||
Cash and Cash Equivalents at Beginning of Period | 1,468.2 | 1,014.8 | |||
Cash and Cash Equivalents at End of Period | $ 1,690.4 | $ 1,190.4 | |||
See notes to consolidated financial statements
GUIDANT CORPORATION
Notes to Consolidated
Financial Statements
(In millions, except
per share data)
(unaudited)
The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. Operating results from interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole. In the opinion of management, the consolidated financial statements reflect all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the Companys results for the periods presented. The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures at the date of the financial statements and during the reporting period. Actual results could differ from these estimates.
For further information, including the Companys significant accounting policies, refer to the consolidated financial statements and notes thereto included in the Companys Annual Report on Form 10-K for the year ended December 31, 2003. As used herein, the terms the Company and Guidant mean Guidant Corporation and its consolidated subsidiaries.
Certain reclassifications have been made to prior year amounts to conform to current year presentation (see Note 9).
The Company has adopted the disclosure-only provisions of Statement of Financial Accounting Standard (SFAS) 123, Accounting for Stock-Based Compensation, as amended by SFAS 148, Accounting for Stock-Based CompensationTransition and Disclosure. Accordingly, the Company accounts for stock-based compensation under Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations, using the intrinsic value method. The following table illustrates the effect on net income and earnings per share if the Company had applied the fair value recognition provisions of SFAS 123 to all stock-based employee compensation. The fair value of stock options was estimated as of the grant date using the Black-Scholes option-pricing model, the attribution method and a forfeiture rate of 10%. These pro forma amounts may not be representative of the effects on reported net income for future years due to the uncertainty of stock option grant volume and potential changes in assumptions driven by market factors.
Three Months Ended June 30, |
Six Months Ended June 30, | ||||||||
---|---|---|---|---|---|---|---|---|---|
2004 | 2003 | 2004 | 2003 | ||||||
Reported net income (loss) (1) | $ 126.5 | ($ 97.1 | ) | $ 265.9 | ($ 3.7 | ) | |||
Deduct: Stock-based compensation not reflected in | |||||||||
net income (loss), net of tax | 17.6 | 15.1 | 28.0 | 31.0 | |||||
Pro forma net income (loss) | $ 108.9 | ($112.2 | ) | $ 237.9 | ($34.7 | ) | |||
Earnings (loss) per share: | |||||||||
Basic--as reported | $ 0.41 | ($ 0.32 | ) | $ 0.86 | ($0.01 | ) | |||
Basic--pro forma | $ 0.35 | ($ 0.37 | ) | $ 0.77 | ($0.11 | ) | |||
Diluted--as reported | $ 0.39 | ($ 0.32 | ) | $ 0.83 | ($0.01 | ) | |||
Diluted--pro forma | $ 0.34 | ($ 0.37 | ) | $ 0.74 | ($0.11 | ) | |||
(1) Reported amounts include expense associated with restricted stock awards.
On April 1, 2004, Guidant granted options on approximately 3.1 million shares and 610,000 restricted stock awards to over 2,500 employees. Restricted stock awards are expensed ratably over the vesting period. Under this program, stock options will vest ratably over three years and the restricted stock awards will vest primarily on April 1, 2007. For certain executive officers, the restricted stock awards vest over six years, but may be accelerated to three-year vesting, in 1/3 increments, upon achievement of 25%, 50% and 75% appreciation of the 60-day moving average stock price from the date of grant ($63.11 on April 1, 2004). Grants may vest earlier upon a qualifying disability, death, retirement or change in control.
Note 3 Inventories
Inventories consisted of the following:
June 30, 2004 |
December 31, 2003 | ||||
---|---|---|---|---|---|
Finished products | $191.3 | $172.9 | |||
Work in process | 69.9 | 81.5 | |||
Raw materials and supplies | 136.8 | 147.5 | |||
$398.0 | $401.9 | ||||
Provisions for estimated expenses related to product warranties are recorded at the time the products are sold. Estimates for warranty costs are calculated based primarily upon historical warranty experience, but may include assumptions related to anticipated changes in warranty costs and failure rates. Warranty cost accruals are adjusted from time to time when warranty claim experience differs from estimates. A summary of the changes in the product warranty activity is as follows:
Six Months Ended June 30, | |||||
---|---|---|---|---|---|
2004 | 2003 | ||||
January 1 | $ 22.3 | $ 18.8 | |||
Provisions for product warranties | 4.5 | 3.3 | |||
Settlements during the period | (7.9) | (4.2) | |||
June 30 | $ 18.9 | $ 17.9 | |||
GUIDANT CORPORATION
Notes to Consolidated
Financial Statements
The following table sets forth the computation of earnings (loss) per share:
Three Months Ended June 30, |
Six Months Ended June 30, | ||||||||
---|---|---|---|---|---|---|---|---|---|
2004 | 2003 | 2004 | 2003 | ||||||
Income (loss) from continuing operations | $ 135.6 | ($81.8) | $ 288.6 | $ 74.6 | |||||
Loss from discontinued operations, net of income taxes | (9.1) | (15.3) | (22.7) | (78.3) | |||||
Net income (loss) | $ 126.5 | ($97.1) | $ 265.9 | ($ 3.7) | |||||
Earnings (loss) per share-basic | |||||||||
Income (loss) from continuing operations | $ 0.44 | ($0.27) | $ 0.93 | $ 0.25 | |||||
Loss from discontinued operations, net of income taxes | (0.03) | (0.05) | (0.07) | (0.26) | |||||
Net income (loss) | $ 0.41 | ($0.32) | $ 0.86 | ($ 0.01) | |||||
Earnings (loss) per share-diluted | |||||||||
Income (loss) from continuing operations | $ 0.42 | ($0.27) | $ 0.90 | $ 0.24 | |||||
Loss from discontinued operations, net of income taxes | (0.03) | (0.05) | (0.07) | (0.25) | |||||
Net income (loss) | $ 0.39 | ($0.32) | $ 0.83 | ($ 0.01) | |||||
Weighted average common shares outstanding | 310.91 | 304.52 | 309.70 | 303.86 | |||||
Effect of dilutive stock options and unvested restricted | |||||||||
stock awards | 9.24 | -- | 9.65 | 6.11 | |||||
Weighted average common shares outstanding | |||||||||
and assumed conversions | 320.15 | 304.52 | 319.35 | 309.97 | |||||
Total options outstanding at June 30, 2004 and 2003 were 41.2 million and 48.3 million. Earnings per share-diluted includes 37.8 million and 39.5 million stock options for the three- and six-month periods ended June 30, 2004 and includes 22.2 million stock options for the six-month period ended June 30, 2003. Stock options with an exercise price greater than the average market value stock price for the period were excluded from the calculation of earnings per share-diluted because including them would have had an anti-dilutive impact. All stock options were excluded from loss per share-diluted for the three-month period ended June 30, 2003, as the impact would have been anti-dilutive.
Comprehensive income (loss) is comprised of net income (loss) adjusted for changes in foreign currency translation adjustments and unrealized gains or losses on foreign currency derivative contracts designated and qualifying as cash flow hedges. For the second quarters of 2004 and 2003, comprehensive income (loss) was $133.1 million and ($70.7) million. Comprehensive income for the six months ended June 30, 2004 and 2003 was $259.3 million and $43.6 million. The increase in comprehensive income was primarily due to net income in 2004, compared to net losses in 2003, partially offset by foreign currency translation losses in 2004 compared to gains in 2003.
GUIDANT CORPORATION
Notes to Consolidated
Financial Statements
Three Months Ended June 30, |
Six Months Ended June 30, | ||||||||
---|---|---|---|---|---|---|---|---|---|
2004 | 2003 | 2004 | 2003 | ||||||
Net Sales(1): | |||||||||
US | $631.3 | $ 628.6 | $1,248.1 | $1,221.8 | |||||
International | 307.5 | 298.0 | 624.8 | 562.7 | |||||
$938.8 | $ 926.6 | $1,872.9 | $1,784.5 | ||||||
(1) Revenues are attributed to countries based on location of the customer.
June 30, 2004 |
December 31, 2003 | ||||
---|---|---|---|---|---|
Property and Equipment, Net: | |||||
US | $706.5 | $660.8 | |||
International | 85.3 | 88.3 | |||
$791.8 | $749.1 | ||||
Three Months Ended June 30, |
Six Months Ended June 30, | ||||||||
---|---|---|---|---|---|---|---|---|---|
Classes of Similar Products: | 2004 | 2003 | 2004 | 2003 | |||||
Net Sales: | |||||||||
Implantable defibrillator | |||||||||
systems | $ 455.7 | $ 376.5 | 860.7 | $ 708.5 | |||||
Pacemaker systems | 183.1 | 171.7 | 362.6 | 330.9 | |||||
Coronary stent systems | 120.4 | 223.0 | 291.8 | 444.0 | |||||
Angioplasty systems | 111.2 | 103.4 | 227.8 | 203.0 | |||||
Cardiac surgery, biliary, peripheral | |||||||||
and carotid systems | 68.4 | 52.0 | 130.0 | 98.1 | |||||
$ 938.8 | $ 926.6 | $1,872.9 | $1,784.5 | ||||||
AFx, inc.: On February 9, 2004, Guidant acquired AFx, inc., a manufacturer of microwave surgical cardiac ablation medical devices. Guidant paid $48.4 million (including transaction expenses) in cash and forgave a $5.8 million extension of credit. The purchase price was allocated to the acquired assets and liabilities based upon fair market values (using the income approach), including a $22.8 million in process research and development (IPRD) charge for technology that had not reached technological feasibility and had no alternative use and $33.0 million for intangible assets related to proven technology. In addition, a deferred tax liability of $12.2 million was recorded for the tax effect of the intangible assets and deferred tax assets of $11.7 million were recorded for the net operating loss carryovers. In order to value the IPRD, a risk-adjusted discount rate of 22.5% was applied to the cash flows. Guidant may make additional payments upon future satisfaction of regulatory, clinical and sales performance criteria. These payments will be recorded when the amount is determinable and will be allocated to the fair value of the intangibles or IPRD, with any amounts paid above fair value of identifiable assets recorded as goodwill.
Biosensors International (Biosensors): In March 2003, the Company completed its acquisition of certain assets of Biosensors everolimus eluting stent program, including an exclusive worldwide license to Biosensors polymer formulation technology in the field of everolimus eluting stents and a nonexclusive license to use this technology with other drugs in drug eluting stents. Additionally, Guidant acquired the option of manufacturing and commercializing Biosensors everolimus eluting stent platform that has been used in Biosensors FUTURE I and II Clinical Trials. Guidant recorded a $20.5 million IPRD charge in connection with the purchase, since technological feasibility of the project had not been attained and the research had no alternative future uses. In June 2003, Guidant recorded a $10.1 million IPRD charge as a result of the achievement of a performance milestone related to six-month clinical data of the everolimus eluting stent trial, FUTURE I. An additional IPRD charge of $50.0 million was recorded in the second quarter of 2004 for clinical results related to Biosensors everolimus eluting stent trial, FUTURE II. Over the course of clinical development, Biosensors may receive additional milestone payments. In addition, Biosensors will receive royalties on future sales of products utilizing Biosensors technology.
Bioabsorbable Vascular Solutions (BVS): In March 2003, Guidant acquired the majority interest in BVS for $10.0 million and accrued an additional $6.0 million for a future clinical milestone. In addition, Guidant purchased the remaining 49% interest for $6.0 million in April 2004. All these amounts are accounted for as IPRD, since technological feasibility of the project has not been attained and the research has no alternative future uses. BVS is developing vascular stent platforms designed to be absorbed by tissue following the restoration of blood flow in patients with coronary artery disease. Guidant may pay milestone payments over the course of clinical development.
X Technologies, Inc. (X Technologies): In June 2003, Guidant acquired X Technologies, the manufacturer of the FDA-approved FX miniRAIL Balloon Dilatation Catheter, a device for the treatment of coronary artery disease. Guidant paid $60.0 million in cash and forgave a $4.5 million extension of credit. The purchase price was allocated to the acquired assets and liabilities based upon fair market values, including $88.7 million to intangible assets related to developed technology and the related deferred tax liability of $32.8 million. Guidant may make additional payments upon future satisfaction of sales performance criteria.
Novartis Pharma AG and Novartis AG (Novartis): In 2002, Guidant entered into an agreement with Novartis that provided Guidant an exclusive worldwide license to use everolimus in drug eluting stents. In the second quarter of 2004, a payment of $15.0 million was made to Novartis for completion of SPIRIT FIRST clinical trial enrollment. This amount was recorded as IPRD, since technological feasibility of the project has not been attained and the research has no alternative future uses.
Certain of Guidants acquisitions involve contingent consideration and certain equity investments may involve contingent payments, which would provide additional ownership to Guidant (collectively referred to as milestone payments). These milestone payments are generally contingent upon reaching performance-related milestones, including specified revenue levels, product development targets or regulatory approvals or filings. At June 30, 2004, Guidants accrual for milestone payments totaled $35.3 million and is expected to be paid during the next two years. In addition, future undiscounted performance-related milestone payments of up to $268.3 million could be paid through 2010, depending on when and if milestones are attained. Potential milestone payments under existing agreements during the next 12 months range from $2.0 to $80.0 million. The Company continues to evaluate business development opportunities, which may generate additional payments.
The operating results of all acquisitions are included in the Companys consolidated financial statements from the date of each acquisition.
In March 2004, Guidants Board of Directors approved a plan to discontinue the GALILEO® Intravascular Radiotherapy System (GALILEO System) product line for the treatment of in-stent restenosis due to the significant competitive impact of drug eluting stents. On April 21, 2004, Guidant signed a definitive agreement with Novoste Corporation (Novoste) to cooperate in assisting existing US and Canadian customers of the GALILEO System who wish to transition to Novoste products. Guidant received $2.5 million upon signing and will receive earn-out payments up to a maximum of $4.0 million based on Novoste sales in the US and Canada. The disposal plan consists primarily of the termination of normal activity, abandonment of property and equipment, product returns, collection of accounts receivable and settlement of liabilities. Net loss from discontinued operations for the six months ended June 30, 2004 includes a charge of $11.2 million, primarily related to the write down of long-lived assets to fair value and recording inventory and accounts receivable at net realizable value.
Guidant expects this discontinuation to occur in several phases, concluding within the next six months. Guidant has taken steps to close the Houston and Pearland, Texas, facilities.
In December 2003, Guidants Board of Directors ratified a plan to discontinue Guidants operations in Brazil due to unfavorable business conditions and poor operating performance.
In June 2003, Guidants Board of Directors approved a plan to dispose of the ANCURE ENDOGRAFT System (ANCURE) product line to treat abdominal aortic aneurysms (AAA) due to continuing financial losses, limited prospects for the Companys AAA product line and the impact of the US Department of Justice investigation.
In accordance with SFAS 144, Accounting for the Impairment or Disposal of Long-Lived Assets, these disposals represent discontinued operations. Accordingly, the accompanying consolidated financial statements and notes reflect the results of operations and financial position of the AAA and GALILEO product lines and the Brazil operations as discontinued operations for all periods presented.
At June 30, 2004, and December 31, 2003, there were $3.9 million and $36.5 million in assets and $25.4 million and $23.9 million in liabilities related to discontinued operations. Assets are primarily comprised of accounts receivable, inventory and property, plant and equipment. Liabilities primarily include accruals for severance, product returns, ANCURE-related settlements and lease commitments. Net loss from discontinued operations includes charges related to the impairment of certain long-lived assets, inventory write-downs, customer returns, ANCURE-related settlements, employee severance and facility costs. Loss from discontinued operations before income taxes, for the six months ended June 30, 2003, includes a $62.4 million charge for the previously disclosed agreement with the US Department of Justice surrounding the ANCURE product line for the treatment of AAA.
The following summarizes financial information for discontinued operations:
Three Months Ended June 30, |
Six Months Ended June 30, | ||||||||
---|---|---|---|---|---|---|---|---|---|
2004 | 2003 | 2004 | 2003 | ||||||
Net sales | $ 4.1 | $ 21.4 | $ 15.4 | $ 48.9 | |||||
Loss from discontinued operations before income taxes | (15.0) | (41.5) | (36.1) | (105.5) | |||||
Net loss from discontinued operations | (9.1) | (15.3) | (22.7) | (78.3) |
For the six months ended June 30, 2004 Guidants Board of Directors declared total dividends of $0.20 per common share outstanding compared to $0.08 per common share outstanding for the first six months ended June 30, 2003.
On July 21, 2004 Guidants Board of Directors approved a management action that will include work force reductions and termination of certain contracts, resulting primarily from the weakness in the metallic coronary stent market. The pre-tax expense associated with this plan is estimated between $50.0 million and $70.0 million and will be recorded during the third quarter of 2004. This charge includes severance, benefits packages for affected employees, contract termination costs and other related costs.
The description of legal proceedings in Part II, Item 1 (Legal Proceedings) to this filing is incorporated herein by reference.
Item 2. Managements
Discussion and Analysis of Results of Operations and Financial Condition
(unaudited)
Guidant Corporation provides innovative, therapeutic medical solutions of distinctive value for customers, patients and healthcare systems around the world. Guidants lifesaving medical technologies are designed to extend the lives and improve the quality of life of millions of patients suffering from life-threatening cardiac and vascular disease. Approximately 12,000 employees develop, manufacture and market the Companys medical devices in nearly 100 countries, with key operations in the US, Europe and Asia. As used herein, the terms the Company and Guidant mean Guidant Corporation and its consolidated subsidiaries.
Cardiovascular disease is the leading cause of death for both men and women in the US today and claims more lives each year than the next five leading causes of death combined. Within cardiovascular disease, Guidant develops, manufactures and markets products that focus on the treatment of coronary arrhythmias, heart failure and coronary and peripheral disease including:
| Implantable defibrillator systems used to detect and treat abnormally fast heart rhythms (tachycardia) that could result in sudden cardiac death (SCD), including implantable cardiac resynchronization therapy defibrillator (CRT-D) systems used to treat heart failure |
| Implantable pacemaker systems used to manage slow or irregular heart rhythms (bradycardia), including implantable cardiac resynchronization therapy pacemaker (CRT-P) systems used to treat heart failure |
| Coronary stent systems for the treatment of coronary artery disease |
| Angioplasty systems including dilatation catheters and related accessories for the treatment of coronary artery disease |
| Cardiac surgery systems |
| Peripheral systems, including those to treat biliary, peripheral vascular and carotid artery disease |
Guidant reported $938.8 million in worldwide sales for the quarter ended June 30, 2004, representing 1% growth compared to the same period in 2003. The impact of fluctuations in foreign currency exchange rates increased sales by $17.0 million, or 2%, partially offset by price declines of 1%. All product lines, except coronary stent systems, experienced growth during the second quarter of 2004. US sales of $631.3 million remained relatively flat compared to the prior year and international sales of $307.5 million increased 3%. Sales of products other than worldwide coronary stent systems represented 87% of total revenues and increased 16% in the second quarter 2004 compared to the second quarter 2003.
Sales for the six months ended June 30, 2004, of $1,872.9 million, increased $88.4 million, or 5% over the same period in 2003. The impact of fluctuations in foreign currency exchange rates increased sales by $49.9 million, or 3%, volume increased sales 5% and price declines decreased sales 3%. US sales of $1,248.1 million grew 2% over the prior year due to an increase in volume, while international sales of $624.8 million increased 11%.
June 30, 2004 | June 30, 2003 | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(In millions) | US | Int'l. | Total | US | Int'l. | Total | Growth | ||||||||
Implantable defibrillator systems | $363.7 | $ 92.0 | $455.7 | $306.7 | $ 69.8 | $376.5 | 21% | ||||||||
Pacemaker systems | 111.2 | 71.9 | 183.1 | 107.8 | 63.9 | 171.7 | 7% | ||||||||
Coronary stent systems | 51.2 | 69.2 | 120.4 | 123.5 | 99.5 | 223.0 | (46%) | ||||||||
Angioplasty systems | 51.5 | 59.7 | 111.2 | 49.0 | 54.4 | 103.4 | 8% | ||||||||
Cardiac surgery, biliary, peripheral | |||||||||||||||
and carotid systems | 53.7 | 14.7 | 68.4 | 41.6 | 10.4 | 52.0 | 32% | ||||||||
$631.3 | $307.5 | $938.8 | $628.6 | $298.0 | $926.6 | 1% | |||||||||
June 30, 2004 | June 30, 2003 | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(In millions) | US | Int'l. | Total | US | Int'l. | Total | Growth | ||||||||
Implantable defibrillator systems | $ 687.4 | $ 173.3 | $ 860.7 | $ 579.7 | $ 128.8 | $ 708.5 | 21% | ||||||||
Pacemaker systems | 215.4 | 147.2 | 362.6 | 209.5 | 121.4 | 330.9 | 10% | ||||||||
Coronary stent systems | 137.4 | 154.4 | 291.8 | 257.9 | 186.1 | 444.0 | (34%) | ||||||||
Angioplasty systems | 105.5 | 122.3 | 227.8 | 96.0 | 107.0 | 203.0 | 12% | ||||||||
Cardiac surgery, biliary, peripheral | |||||||||||||||
and carotid systems | 102.4 | 27.6 | 130.0 | 78.7 | 19.4 | 98.1 | 33% | ||||||||
$1,248.1 | $ 624.8 | $1,872.9 | $1,221.8 | $ 562.7 | $1,784.5 | 5% | |||||||||
Implantable Defibrillator (ICD) Systems
Worldwide sales of implantable defibrillator systems in the second quarter of 2004 were $455.7 million, an increase of 21% over the same period in 2003. Growth was driven primarily by increased volume, including a shift toward higher-value CRT-D systems. US implantable defibrillator system sales increased 19% to $363.7 million and international sales increased 32% to $92.0 million in the second quarter of 2004 compared to the same period in the prior year. For the first six months of 2004, worldwide ICD system sales were $860.7 million, an increase of 21% over the same period in the prior year. Sales of ICD systems increased due to the following:
| Increased awareness for implantable defibrillator and cardiac resynchronization therapies based upon the findings of two Guidant-sponsored clinical trials MADIT II and COMPANION. MADIT II demonstrated that a broader group of patients would benefit from implantable defibrillator therapy. The investigators for the COMPANION trial reported that for advanced heart failure patients with desynchronized heart contractions, the addition of resynchronization therapy to optimal drug treatment reduced the combination of death or hospitalization when compared with optimal drug treatment alone. This trial demonstrated 20% reduction in combined all-cause death and hospitalization by adding Guidants CRT-D systems to optimal drug therapy and 36% reduction in all-cause mortality for Guidants CRT-D systems for patients with advanced heart failure. The COMPANION trial was published in May 2004 in the New England Journal of Medicine. |
| Continued acceptance of the following: |
| VITALITY® family of implantable defibrillator systems, primarily the VITALITY DS and VITALITY 2 |
| CONTAK® RENEWAL family of CRT-D systems, primarily the RENEWAL 3 and RENEWAL 4 |
In July 2004, Guidant received Conformité Européenne (CE) Mark approval of its CONTAK RENEWAL® 4 AVT cardiac resynchronization therapy defibrillator, designed to treat heart failure patients who are at risk for sudden cardiac death and also suffer from atrial arrhythmias. In May 2004 Guidant launched the VITALITY 2 implantable defibrillator system in the US. This device incorporates Guidants RHYTHM ID® feature, which utilizes rhythm discrimination technology to distinguish between lethal and non-lethal heart rhythms to deliver the appropriate care.
The National Heart, Lung and Blood Institutes SCD-HeFT clinical trial has been completed, and the preliminary clinical trial results were presented in March 2004 at the American College of Cardiology Annual Scientific Session. The results demonstrated positive benefits of implantable defibrillators (reducing death by 23% versus patients who did not receive defibrillators) in patients with heart failure. The Centers for Medicare & Medicaid Services (CMS) has indicated that it may consider the SCD-HeFT results as evidence to further expand reimbursement coverage for implantable defibrillators. Guidant formally joined in support of the petition to CMS for full SCD-HeFT patient population ICD coverage. The following may impact the implantable defibrillator market:
| Recent entry of a new competitor in the resynchronization segment |
| Expected publication of SCD-HeFT clinical trial results |
| Recent publication of the COMPANION trial |
| Potential expanded indication and reimbursement supported by both COMPANION and SCD-HeFT clinical trials. In July 2004, the Circulatory System Devices Panel of the FDA unanimously recommended approval, with conditions, of expanded user labeling, including indications, for Guidant cardiac resynchronization therapy defibrillators based on the results of the COMPANION clinical trial. The FDA will now consider the panels recommendation prior to making its final decision. |
Pacemaker Systems
Worldwide pacemaker system sales were $183.1 million for the quarter ended June 30, 2004, a 7% increase over the same period in the prior year. US pacemaker system sales grew 3% to $111.2 million and international sales grew 13% to $71.9 million. Worldwide sales of these products for the first six months of 2004 were $362.6 million, an increase of $31.7 million or 10% over the same period in 2003. Pacemaker system sales growth was primarily due to a shift toward higher-value CRT-P systems driven by the acceptance of the CONTAK RENEWAL TR 2 CRT-P system, launched in the third quarter of 2003 in Europe and the CONTAK RENEWAL TR CRT-P system launched in the US in January 2004.
Coronary Stent Systems
Worldwide coronary stent system sales for the second quarter of 2004 were $120.4 million, a decline of 46% compared to the second quarter of 2003. Coronary stent system sales comprised 24% of sales in the second quarter of 2003 and have now declined to 13% in the second quarter of 2004. Coronary stent system sales in the US were $51.2 million for the second quarter of 2004 compared to $123.5 million for the second quarter of 2003. Increasing penetration of competitive drug eluting stents in the US primarily drove this decline. International sales for the second quarter of 2004 and 2003 were $69.2 million and $99.5 million. This decrease was primarily due to declining stent sales in Japan as a result of competitive metallic stent launches since late 2003. Further decreases are expected in Japan when the full launch of a competitors drug eluting stent occurs in the second half of 2004. In February 2004, Guidant entered into an agreement with Johnson & Johnson to co-promote Cordis CYPHER Sirolimus-eluting Coronary Stent. This agreement also allows for co-promotion of future drug eluting stents sold by Johnson & Johnson. Co-promotion commissions earned by Guidant under this agreement, along with sales of stent delivery systems (dilatation catheters) to Johnson & Johnson, are included in US coronary stent system sales. Worldwide coronary stent system sales for the first six months of 2004 were $291.8 million compared to $444.0 million for the same period in the prior year. International sales were $154.4 million in the first six months of 2004 compared to $186.1 million in the first six months of 2003. Continued decreases in coronary stent system sales are expected until Guidant directly participates in the drug eluting stent market. Coronary stent system sales in 2004 primarily include:
| MULTI-LINK VISION® Coronary Stent System |
| MULTI-LINK ZETA® Coronary Stent System |
| MULTI-LINK PENTA® Coronary Stent System |
| MULTI-LINK PIXEL® Coronary Stent System |
In May 2004, Guidant announced CE Mark approval and launch of the MULTI-LINK MINI VISION Coronary Stent System, a cobalt chromium stent designed for treating coronary artery disease in small vessels. In April 2004, Guidant announced CE Mark approval of the MULTI-LINK FRONTIER Coronary Bifurcation Stent System, which is specifically designed to treat plaque in coronary arteries at the site of a bifurcation, where one vessel branches from another. In July 2004, Guidant announced Japan regulatory approval and launch of the MULTI-LINK ZETA Coronary Stent System.
Angioplasty Systems
Angioplasty system sales totaled $111.2 million in the second quarter of 2004 compared to $103.4 million in the second quarter of 2003, reflecting 8% sales growth. Sales of these products for the six months ended June 30, 2004, were $227.8 million compared to $203.0 million for the same period in the prior year, an increase of 12%. During the second and third quarter of 2004, Guidant announced FDA approval and launched the over-the-wire VOYAGER (OTW) and the rapid exchange VOYAGER (RX) Coronary Dilatation Catheters.
Cardiac Surgery, Biliary, Peripheral and Carotid Systems
Worldwide sales of cardiac surgery, biliary, peripheral and carotid systems totaled $68.4 million in the second quarter of 2004, representing 32% growth over the same period in 2003. Sales for these systems during the first six months of 2004 were $130.0 million compared to $98.1 million for the same period in 2003, representing a 33% increase. Sales growth was driven by:
| Continued growth in the endoscopic vessel harvesting market driven by adoption of the VASOVIEW® Endoscopic Vessel Harvesting System |
| ..035 Platforms: ABSOLUTE Self Expanding Stent, OMNILINK® Balloon Expandable Stent and AGILTRAC Peripheral Dilatation Catheter |
| RX ACCULINK Carotid Stent System in Europe and the RX ACCUNET Embolic Protection System |
Cost of Products Sold
Cost of products sold was $234.6 million and $460.9 million in the second quarter of 2004 and six months ended June 30, 2004, compared to $224.5 million and $429.6 million for the same respective periods in 2003. Gross profit percentage was 75.0% for the second quarter of 2004 and 75.4% for six months ended June 30, 2004, compared to 75.8% for the second quarter of 2003 and 75.9% for the six months ended June 30, 2003. The change in gross profit percentages was primarily driven by the decrease in sales of stents in the US and Japan, partially offset by continued sales mix shift toward higher value implantable defibrillator systems, including CRT-D systems. Guidant has implemented a lean manufacturing initiative across the cardiac rhythm management product lines. This initiative is expected to improve inventory management throughout the supply chain and serve to reduce raw material levels in the short term. Over the long term this will improve responsiveness of the supply chain and help offset the Companys decreasing gross profit percentage due to decreasing stent sales.
Guidant continued its commitment to product innovation by increasing its investment in research and development in the second quarter of 2004. Research and development expense was $136.8 million for the second quarter of 2004, or 14.6% of sales, compared to $129.4 million in the second quarter of 2003, or 14.0% of sales. Research and development expense for the first six months of 2004 totaled $274.4 million (14.7% of sales) compared to $242.2 million (13.6% of sales) in the same period in 2003. Significant investments in research and development in the first half of 2004 included:
| Guidants two primary drug eluting stent programs: |
| CHAMPION Everolimus Eluting Coronary Stent System mounted on the MULTI-LINK VISION stent delivery system. This system includes a bioabsorbable polymer matrix and is being evaluated in the FUTURE family of clinical trials. |
| MULTI-LINK VISION Everolimus Eluting Stent System, which is currently being evaluated in the SPIRIT FIRST Clinical Trial and includes a durable polymer matrix. SPIRIT FIRST is a feasibility study for durable polymer drug eluting stent to support filings for larger US and European pivotal trials. |
| Bioabsorbable stent research and development |
| Advanced Patient Management applications, designed to enable physicians to monitor patient heart function remotely and automatically |
| Clinical trials to further demonstrate the benefits of cardiac resynchronization therapy devices for treating heart failure |
| Development of next-generation devices for cardiac rhythm management, carotid stent systems and cardiac surgery products |
Important research and development events in 2004 included:
| DECREASE HF Clinical Trial Heart failure study designed to demonstrate the safety and effectiveness of the flexible pacing modes offered in Guidants newest CRT-D systems. Enrollment of 360 patients was completed in April 2004. |
| CONTAK RENEWAL 3 AVT Clinical Trial Study designed to determine the effect of device therapy in patients who suffer from both heart failure and atrial arrhythmias. Guidant expects to complete enrollment in the third quarter of 2004. |
| FUTURE II Clinical Trial Study designed to evaluate the safety of the CHAMPION Everolimus Eluting Coronary Stent System compared to a metallic stent platform in previously untreated lesions. The Company announced positive one-year results in May 2004, which confirmed the positive six-month results presented in September 2003. |
| SPIRIT FIRST Clinical Trial Enrollment of 60 patients was completed in April 2004 and 30-day Major Adverse Cardiac Event (MACE) results were reported. |
| Acculink for Revascularization of Carotids in High Risk Patients (ARCHeR) Clinical Trial Study designed to evaluate the safety and effectiveness of carotid artery stenting as a minimally invasive alternative for treating carotid artery disease in patients ineligible for surgery or at high surgical risk. In March 2004, the Company announced positive one-year results for the ARCHeR 1 and 2 Clinical Trials and positive 30-day results for the ARCHeR 3 Clinical Trial. |
The Company, subject to completion of appropriate clinical trials and receipt of regulatory approvals, expects to launch its first drug eluting stent in Europe in 2005 and in the US in 2007.
Guidant recorded pre-tax IPRD charges of $73.0 million and $99.8 million for the three- and six-month periods ended June 30, 2004. This compares to $12.0 million and $48.5 million for the comparable periods in the prior year. Key components of these charges include:
2004
| Biosensors International (Biosensors)$50.0 million recorded during the second quarter of 2004 in conjunction with milestones related to the FUTURE II clinical trial |
| Novartis Pharma AG and Novartis AG$15.0 million payment for completion of SPIRIT FIRST clinical trial enrollment that occurred in April 2004 |
| Bioabsorbable Vascular Solutions (BVS)$6.0 million payment to purchase the remaining interest of BVS, an early-stage developer of bioabsorbable stents, in April 2004. Bioabsorbable stents are designed to be absorbed by tissue following the restoration of blood flow in patients with coronary artery disease. |
| AFx, inc.-$22.8 million associated with the February 2004 acquisition of AFx, inc., a manufacturer of microwave surgical cardiac ablation medical devices |
The remaining charges in 2004 were primarily for the purchase of technology to be utilized in conjunction with Guidants carotid embolic protection systems.
2003
| BiosensorsIn March 2003, Guidant purchased certain assets of Biosensors everolimus eluting stent program, resulting in $20.5 million IPRD. In June 2003, Guidant recorded a $10.1 million IPRD charge as a result of the achievement of a performance milestone related to six-month clinical data of the everolimus eluting stent trial, FUTURE I. |
| BVS-In March 2003, Guidant purchased the majority interest in BVS, resulting in a $16.0 million IPRD charge |
Sales, marketing and administrative expenses were $298.1 million for the three months ended June 30, 2004, relatively unchanged from the same period in 2003, due to spending controls. These expenses for the six months ended June 30, 2004, totaled $612.8 million compared to $566.2 million for the same period in 2003, an increase of 8%. The increases for the six-month period were driven primarily by compensation associated with sales growth and the increase in the cardiac rhythm management sales force.
On July 21, 2004 Guidants Board of Directors approved a management action that will include work force reductions and termination of certain contracts, resulting primarily from the weakness in the metallic stent market. The pre-tax expense associated with this plan is estimated between $50.0 million and $70.0 million and will be recorded during the third quarter of 2004. This charge includes severance, benefits packages for affected employees, contract termination costs and other related costs. This initiative, along with other structural spending controls, is expected to decrease sales, marketing, administrative and research and development expenses by approximately 8-13% in the second half of 2004 compared to the first half of 2004. This management action is expected to provide an improved cost structure in future years. In connection with this action, the Company changed its bonus programs in a manner expected to reduce bonus compensation in the second half of 2004, including the elimination of the management committee bonuses for all of 2004.
Net interest income was ($0.2) million for the three months ended June 30, 2004, compared to ($2.5) million for the same period in 2003. Net interest income was ($1.2) million for the six months ended June 30, 2004, compared to ($3.9) million for the same period in 2003. The decrease in net interest income from 2003 was driven by a higher average outstanding debt balance, which was partially mitigated by increased interest income from larger balances in cash and cash equivalents and short-term investments.
Three Months Ended June 30, |
Six Months Ended June 30, | ||||||||
---|---|---|---|---|---|---|---|---|---|
2004 | 2003 | 2004 | 2003 | ||||||
Interest income | ($6.6) | ($5.9) | ($12.8) | ($11.6) | |||||
Interest expense | 6.4 | 3.4 | 11.6 | 7.7 | |||||
Interest, net | ($0.2) | ($2.5) | ($1.2) | ($3.9) | |||||
Royalty expense is incurred for sales of certain implantable defibrillator systems, pacemaker systems, coronary stent systems and angioplasty systems. Net royalty expense totaled $12.5 million in the second quarter of 2004 compared to $15.7 million for the same period in 2003. These expenses for the six months ended June 30, 2004, totaled $24.6 million compared to $29.0 million in the same period in the prior year. Net royalty expense included royalty income of less than $1.0 million in all periods presented. The decrease in royalty expense was primarily due to the December 2003 expiration of a Mirowski patent covering certain implantable defibrillator products. At the end of the second quarter, the Company has accrued $58.7 million, which represents all royalties and interest potentially payable under the license agreement pertaining to that patent. The ultimate payment will depend on a decision by the Federal Circuit Court of Appeals ruling on a competitors challenge to the patents validity, claim construction and term extension. (See Part II, Item 1, Legal Proceedings.)
Amortization for other intangible assets was $7.7 million in the second quarter of 2004 compared to $3.3 million in the second quarter of 2003. These expenses for the six months ended June 30, 2004, totaled $15.0 million compared to $6.5 million for the same period in 2003. The increases are attributable to the intangibles recorded in conjunction with the June 2003 acquisition of X Technologies, Inc. and the February 2004 acquisition of AFx, inc.
Other, net was $6.4 million in the second quarter of 2004 compared to $0.4 million in the second quarter of 2003, and $8.9 million and $5.7 million for the six months ended June 30, 2004 and 2003. For all periods presented this line item primarily includes losses on sale of fixed assets and write downs of equity investments and fixed assets. The increase in expense during 2004 compared to 2003 is primarily due to impairments of equity investments that were considered other than temporary.
The effective income tax rates for the quarters ended June 30, 2004 and 2003 were 20.2% and (53.6%). The income tax rates for the six-month periods ending June 30, 2004 and 2003 were 23.6% and (96.8%) ($36.7 million tax benefit). The effective tax rate change in 2004 was primarily due to the litigation settlement in 2003 that was deductible at the US statutory tax rates. Guidants ongoing operations are impacted by overseas operations having statutory tax rates that are lower than the US statutory tax rates.
The Company recorded a $422.8 million net litigation charge in the second quarter of 2003 primarily related to the arbitration decision involving Cordis Corporation.
In March 2004, Guidants Board of Directors approved a plan to discontinue the GALILEO Intravascular Radiotherapy System (GALILEO System) product line for the treatment of in-stent restenosis due to the significant competitive impact of drug eluting stents. On April 21, 2004, Guidant signed a definitive agreement with Novoste Corporation (Novoste) to cooperate in assisting existing US and Canadian customers of the GALILEO System who wish to transition to Novoste products. Guidant received $2.5 million upon signing and will receive earn-out payments up to a maximum of $4.0 million based on Novoste sales in the US and Canada. The disposal plan consists primarily of the termination of normal activity, abandonment of property and equipment, product returns, collection of accounts receivable and settlement of liabilities. Net loss from discontinued operations for the six months ended June 30, 2004 includes a charge of $11.2 million, primarily related to the write down of long-lived assets to fair value, severance-related charges and recording inventory and accounts receivable at net realizable value. Guidant expects this discontinuation to occur in several phases, concluding within the next six months. Guidant has taken steps to close the Houston and Pearland, Texas, facilities.
In addition, Guidants Board of Directors ratified a plan in December 2003 to discontinue Guidants operations in Brazil due to unfavorable business conditions and poor operating performance.
In June 2003, Guidants Board of Directors approved a plan to dispose of the ANCURE ENDOGRAFT System (ANCURE) product line to treat abdominal aortic aneurysms (AAA) due to continuing financial losses, limited prospects for the Companys AAA product line and the impact of the US Department of Justice investigation.
In accordance with SFAS 144, Accounting for the Impairment or Disposal of Long-Lived Assets, these disposals represent discontinued operations. Accordingly, the accompanying consolidated financial statements and notes reflect the results of operations and financial position of the AAA and GALILEO product lines and the Brazil operations as discontinued operations for all periods presented.
At June 30, 2004, and December 31, 2003, there were $3.9 million and $36.5 million in assets and $25.4 million and $23.9 million in liabilities related to discontinued operations. Assets are primarily comprised of accounts receivable, inventory and property, plant and equipment. Liabilities primarily include accruals for severance, product returns, litigation accruals and lease commitments. Net loss from discontinued operations includes charges related to the impairment of certain long-lived assets, inventory write-downs, customer returns, ANCURE-related settlements, employee severance and facility costs. Loss from discontinued operations before income taxes, for the six months ended June 30, 2003, includes a $62.4 million charge for the previously disclosed agreement with the US Department of Justice surrounding the ANCURE product line for the treatment of AAA. The Company expects to incur pre-tax losses of up to $25.0 million associated with the exit of these three businesses for the remainder of 2004, excluding litigation charges (see Part II, Item 1, Legal Proceedings).
The following summarizes financial information for discontinued operations (in millions):
Three Months Ended June 30, |
Six Months Ended June 30, | ||||||||
---|---|---|---|---|---|---|---|---|---|
2004 | 2003 | 2004 | 2003 | ||||||
Net sales | $4.1 | $21.4 | $15.4 | $ 48.9 | |||||
Loss from discontinued operations before income taxes | (15.0) | (41.5) | (36.1) | (105.5) | |||||
Net loss from discontinued operations | (9.1) | (15.3) | (22.7) | (78.3) |
June 30, 2004 | December 31, 2003 | ||||
---|---|---|---|---|---|
(Dollars in millions) | |||||
Cash and cash equivalents (1) | $ 1,690.4 | $ 1,468.2 | |||
Working capital | $ 2,381.4 | $ 2,017.5 | |||
Current ratio | 3.4:1.0 | 2.9:1.0 | |||
Net cash position (2) | $ 836.9 | $ 519.9 | |||
Days receivable outstanding | 79 | 78 | |||
Inventory turnover | 2.31 | 2.38 |
(1)
A substantial portion of cash and cash equivalents is indefinitely invested
in Guidants non-US subsidiaries.
(2) Net cash position is the sum
of cash and cash equivalents and short-term investments less total debt.
Certain of Guidants acquisitions involve contingent consideration and certain equity investments may involve contingent payments, which would provide additional ownership to Guidant (collectively referred to as milestone payments). These milestone payments are generally contingent upon reaching performance-related milestones, including specified revenue levels, product development targets or regulatory approvals or filings. At June 30, 2004, Guidants accrual for milestone payments totaled $35.3 million and will be paid during the next two years. In addition, future undiscounted performance-related milestone payments of up to $268.3 million could be paid through 2010, depending on when and if milestones are attained. Potential milestone payments under existing agreements during the next 12 months range from $2.0 to $80.0 million. The Company continues to evaluate business development opportunities, which may generate additional payments.
Six Months Ended June 30, |
|||||||
---|---|---|---|---|---|---|---|
2004 | 2003 | Change | |||||
(In millions) | |||||||
Net cash provided by (used for): | |||||||
Operating activities | $ 495.5 | $ 243.5 | $ 252.0 | ||||
Investing activities | (337.1 | ) | (230.7 | ) | (106.4 | ) | |
Financing activities | 67.5 | 80.2 | (12.7 | ) | |||
Effect of exchange rate changes on cash | (3.7 | ) | 82.6 | (86.3 | ) | ||
Net increase in cash and cash equivalents | $ 222.2 | $ 175.6 | $ 46.6 | ||||
Net cash provided by operating activities was $495.5 million for the first six months of 2004, an increase of $252.0 million primarily due to a decrease in tax payments of $94.2 million during the six months ended June 30, 2004 compared to the six months ended June 30, 2003.
Net cash used for investing activities was $337.1 million for the first six months of 2004, an increase of $106.4 million from the prior year primarily due to an increase of $122.3 million for purchases of equity and short-term investments. The majority of these purchases are interest-bearing investments with maturities between three and six months.
Net cash provided by financing activities was $67.5 million for the first six months of 2004, a decrease of $12.7 million from the prior year due to the following:
| $127.2 million increase in repurchases of common stock |
| $37.6 million increase in dividend payments |
| $56.1 million decrease in additional borrowings |
partially offset by:
| $208.2 million increase in issuances of common stock for stock option exercises |
Exchange rate fluctuations decreased cash by $3.7 million for the six months ended June 30, 2004 compared to an increase in cash of $82.6 million for the six months ended June 30, 2003. This decrease of $86.3 million is primarily due to the Euro weakening during the six months ended June 30, 2004 and strengthening during the six months ended June 30, 2003 compared to the US dollar.
At June 30, 2004, the Company had outstanding borrowings of $954.1 million at a weighted average interest rate of 2.21%, including bank borrowings, commercial paper, $350.0 million principal balance in long-term notes due in 2006 and interest rate swap agreements valued at $3.4 million. Bank borrowings represent advances under short-term uncommitted credit facilities with commercial banks. The commercial paper borrowings are supported by two credit facilities; a $400.0 million facility that expires August 2007 and a $400.0 million facility that expires August 2004. The Company is currently renegotiating the credit facility that expires August 2004. There are currently no outstanding borrowings under these facilities. The Company classified $250.0 million as short-term debt at June 30, 2004. The Company believes that cash and cash equivalent balances will be adequate to fund maturities of short-term borrowings, obligations to make interest payments on its debt and other anticipated operating cash needs for 2004, including planned capital expenditures of approximately $135.0 million for the remainder of 2004.
The Company has recognized net deferred tax assets aggregating $298.9 million at June 30, 2004, compared to $314.1 million at December 31, 2003. In view of the consistent profitability of its past operations, the Company believes that these assets will be substantially recovered and that no significant additional valuation allowances are necessary.
As further described in the Companys Annual Report on Form 10-K and Exhibit 99 to this filing, the medical device industry is subject to substantial regulation, including by the FDA and comparable international agencies. In addition to requiring clearance or approval to market new or improved devices, the Company is subject to regulation as a device manufacturer. Regulations cover many aspects of the Companys operations, including quality systems, marketing and device reporting.
From time to time, the Company initiates field actions with respect to market-released products. These actions may include product recalls or communications with a significant number of physicians about a product or labeling issue. The scope of such actions can range from very minor issues affecting a small number of units to more significant actions. Since the Companys last filing on Form 10-Q, the Company conducted the following field actions:
In June, Guidant initiated a field action in Japan related to product labeling of the Pulsar/Discovery II pacemaker systems. Changes to product labeling, including the Physician Technical Manual and labels on programming devices, were completed; however, no product was required to be returned. Affected physicians and the Japanese Ministry of Health, Labor and Welfare (MHLW) were notified.
In June, Guidant initiated a field action in Japan related to the ENDOTAK ENDURANCE® EZ lead, distributed only in Japan. Root cause analysis identified a small number of devices potentially affected. Physicians with suspect leads implanted were provided with diagnostic and follow-up recommendations and the MHLW was notified.
Certain statements made in this report are forward-looking, including accounting estimates, statements concerning sales and expense trends, anticipated tax rates, capital expenditures, cash flows, costs of research programs, the timing of discontinued operations and the timing of product developments. The statements are based on assumptions about many important factors, including assumptions concerning:
| The development of the coronary stent market: Drug eluting stents present a significant growth opportunity; however, the earlier introduction of drug eluting stents by the Companys competitors has substantially affected the market for metallic coronary stents and will continue to impact the Companys financial results. |
| The effects of operating in an industry subject to complex regulation, the necessity for appropriate reimbursement of therapies and the significance of legal claims in Guidants industry. |
| Changes in the location or volume of production or changes in tax law. |
| Product development and production factors (including the uncertainties associated with clinical trials), competitive factors (including the introduction of new products and alternative therapies), business development factors, internal factors (including the retention of key employees and changes in business strategies) and others, all as further described in Exhibit 99 to this filing, which is incorporated herein by reference. |
Actual results may differ materially. The Company does not undertake to update its forward-looking statements.
An evaluation was carried out, under the supervision of and with the participation of the Companys management, including the Companys chief executive officer (CEO) and chief financial officer (CFO), of the effectiveness of the Companys disclosure controls and procedures as of the end of the period covered by this report. Based on the evaluation, the CEO and CFO have concluded that the Companys disclosure controls and procedures are effective.
There was no change in the Companys internal control over financial reporting during the Companys most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect the Companys internal control over financial reporting.
Section 404 of the Sarbanes-Oxley Act requires company management to assess and report on the companys internal controls. It also requires a companys independent, outside auditors to issue an attestation to managements assessment, as well as assess the proper design and function of internal controls. Guidant is required to comply with this requirement for the first time as of December 31, 2004. Guidant has substantially completed the documentation to comply with this standard and is now working on management testing of internal controls.
The Company is involved in patent, product liability, shareholder and other legal proceedings that arise in the course of the Companys business. The Company records a liability when a loss is considered probable and the amount can be reasonably estimated. If the reasonable estimate of a probable loss is a range, and no amount within the range is a better estimate, the lower end of the range is accrued. If a loss is not probable or a probable loss cannot be reasonably estimated, no liability is recorded.
Patent and other proprietary rights are essential to the Companys business. Significant litigation concerning patents and products is pervasive in the Companys industry. Patent claims include challenges to the coverage and validity of the Companys patents on products or processes as well as allegations that the Companys products infringe patents held by competitors or other third parties. Although the Company believes that it has valid defenses to these challenges with respect to material patents, there can be no assurance as to the outcome of these matters, and a loss in any of these cases could result in a loss of patent protection or the ability to market products, which could lead to a significant loss of sales, or otherwise materially affect future results of operations.
Losses in the matters below are not considered probable or cannot be reasonably estimated. Accordingly, the Company has not recorded reserves for these matters. While the liability of the Company in connection with the claims cannot be estimated with any certainty, the outcome of these legal proceedings, except as specifically identified below, is not expected to have a material adverse effect on the Companys consolidated financial position, although the resolution in any reporting period of one or more of these matters could have a significant impact on the Companys results of operations for that period. While the Company believes that it has valid defenses in these matters, litigation is inherently uncertain, excessive verdicts do occur, and the Company may in the future incur material judgments or enter into material settlements of claims.
On February 18, 1998, Arterial Vascular Engineering, Inc. (now known as Medtronic Vascular) filed suit against the Companys subsidiary, Advanced Cardiovascular Systems, Inc. (ACS), in the District Court for Delaware alleging that the sale of its balloon-expandable coronary and peripheral stents infringe the Boneau patents owned by Medtronic Vascular. The suit is consolidated with a suit by ACS alleging infringement by Medtronic Vascular of the Companys Lau stent patents. The Medtronic Vascular complaint also alleges misappropriation of trade secrets and breach of a confidentiality agreement by ACS. In the lawsuit, Medtronic Vascular is seeking injunctive relief, co-ownership of the Lau patents, monetary damages and a ruling that the ACS stent patents asserted against Medtronic Vascular are invalid. Pretrial matters are scheduled through 2004, with trial set in the first quarter of 2005. This suit is one of a number of suits brought by Medtronic Vascular under the Boneau patents against all substantial participants in the stent market. The allegations made by Medtronic Vascular are wide-ranging and cover the Companys stent products broadly. Accordingly, while potential liability cannot be estimated with any certainty, an adverse outcome could have a material impact on results of operations or consolidated financial position.
On June 15, 2000, Medtronic, Inc. (Medtronic) filed a declaratory judgment action against the Company and its Cardiac Pacemakers, Inc. (CPI) subsidiary in the District Court for Minnesota requesting that the court rule that Medtronic does not infringe certain of CPIs patents for atrial fibrillation technology or that the patents are not valid. Subsequently, the Company asserted additional patents related to atrial fibrillation technology against Medtronic in the same court. Currently, eight patents are being asserted against Medtronic in this consolidated litigation. Pretrial matters are scheduled into the second half of 2004.
On March 6, 2002, Pacesetter, Inc. (Pacesetter), a subsidiary of St. Jude Medical, Inc. (St. Jude), filed suit against the Companys subsidiaries, CPI and Guidant Sales Corporation (GSC), in the Central District of California alleging that CPI and GSC have infringed a number of Pacesetter patents covering various features of pacemakers and implantable defibrillators. On the Companys motion, the case was transferred to the District Court for Minnesota. Pacesetter is seeking injunctive relief, monetary damages and attorney fees. Currently four patents are at issue. Pacesetter has sought reexamination of two of the patents. On the Companys motion, the litigation has been stayed pending the completion of the reexaminations.
On April 14, 2003, Medinol Ltd. filed suit against the Company and its ACS subsidiary in the Southern District of New York alleging that the sale of the Companys MULTI-LINK ZETA, MULTI-LINK PENTA and MULTI-LINK VISION Coronary Stent Systems infringe five Medinol patents related to stent design. The complaint seeks injunctive relief and monetary damages. Pretrial matters are scheduled through 2004.
On June 12, 2003, the Company announced that its subsidiary, EndoVascular Technologies, Inc. (EVT), had entered into a plea agreement with the US Department of Justice relating to a previously disclosed investigation regarding the ANCURE ENDOGRAFT System for the treatment of abdominal aortic aneurysms. At the time of the EVT plea, the Company had outstanding fourteen suits alleging product liability related causes of action relating to the ANCURE System. The Company settled eleven of the suits that predated the EVT plea for an amount recorded in the third quarter of 2003 that was not material to the Company. Subsequent to the EVT plea, the Company has been notified of additional claims and served with additional complaints. From time to time, the Company has settled certain of the claims and suits for amounts that were not material to the Company. Currently, the Company has outstanding approximately thirty-five suits, and more suits are likely to be filed. A consolidated class action complaint covering ANCURE recipients was also filed in the Northern District of California; however, the plaintiffs have recently voluntarily dismissed their class allegations. The remaining cases allege that plaintiffs died or suffered other injuries as a result of purported defects in the device or the accompanying warnings and labeling. The complaints seek damages, including punitive damages, and equitable relief. An additional complaint includes state-law allegations of unfair trade and business practices relating to sales of the product. While the Company maintains insurance that may serve to reduce the Companys exposure with respect to these claims, one of the Companys carriers, Allianz Insurance Company (Allianz), has filed suit in the Circuit Court, State of Illinois, County of DuPage, seeking to rescind or otherwise deny coverage, and additional carriers have intervened in the case. The Company also has initiated suit against certain of its carriers, including Allianz, in the Superior Court, State of Indiana, County of Marion, in order to preserve the Companys rights to coverage.
Also following the EVT plea, the Company has been served with securities class action and shareholder derivative complaints relating to the ANCURE System. A consolidated securities class action, which names as defendants the Company, EVT and certain of their current and former officers, is pending in the Southern District of Indiana. Generally, it is alleged that during all or a portion of the period from June 23, 1999, through June 12, 2003, public statements by the Company relating to the ANCURE System were false and misleading. Damages are sought on behalf of persons who purchased or otherwise acquired Company shares during that period. The Company has filed a motion to dismiss the case, which motion is fully briefed.
The derivative suits relating to the ANCURE System currently are pending in the Southern District of Indiana and in the Superior Court of the State of Indiana, County of Marion. The suits, purportedly filed on behalf of the Company, generally allege that the Companys directors breached their fiduciary duties by taking improper steps or failing to take steps to prevent the ANCURE and EVT related matters described above. The complaints seek damages and other equitable relief. The state court suits have been stayed in favor of the federal action. The Company has filed a motion to dismiss the federal action, which motion is fully briefed. In connection with the briefing, the court recently certified an issue to the Indiana Supreme Court relating to the plaintiffs obligation to make a demand on the Companys board of directors before filing a lawsuit.
On August 29, 2003, Medtronic filed a declaratory judgment action in the District Court for Delaware against the Company, GSC, Eli Lilly and Company (Lilly), and Mirowski Family Ventures L.L.C. (Mirowski), challenging its obligation to pay royalties to Mirowski on certain devices by alleging the invalidity of certain claims of US patent RE 38,119 (119), which patent relates to cardiac resynchronization therapy and bi-ventricular pacing therapy. The 119 patent is exclusively licensed to the Company as part of a broader license covering Mirowski patents and is sublicensed to Medtronic. The parties have agreed to an expedited proceeding with limited scope and a bench trial is scheduled in the fourth quarter of 2004.
On February 2, 2004, the Company, GSC, CPI and Mirowski filed a declaratory judgment action in the District Court for Delaware against St. Jude and Pacesetter alleging that their Epic HF, Atlas HF, and Frontier 3x2 devices infringe the 119 patent (described in the prior paragraph).
On February 24, 2004, the Companys subsidiary, CPI, filed a patent infringement action in the District Court of Minnesota against St. Jude and Pacesetter alleging that their Quicksite over-the-wire pacing lead has infringed US Patent No. 5,755,766/Reexamination Certificate No. 5,755,766 C1 (766 Patent).
On February 24, 2004, the Company entered into an agreement with Johnson & Johnson (J&J) to co-promote the CYPHER Sirolimus-eluting Coronary Stent in the US. Previously, Boston Scientific Corporation (BSC) sued J&J in the US District Court for the District of Delaware alleging that the CYPHER stent infringes certain patents owned by BSC. On March 16, 2004, BSC filed an amended complaint adding the Company as a defendant. Under the terms of the agreement with J&J, J&J is required to indemnify the Company.
Anna Mirowski, Lilly and two Company subsidiaries, GSC and CPI, are plaintiffs in a patent infringement suit originally filed against St. Jude and its affiliates in November 1996 in the District Court in Indianapolis. The suit alleges that St. Judes defibrillator products infringe patents licensed to CPI. In July 2001, a jury found that two of the licensed patents were valid and that St. Jude had infringed one, a patent that expired in March 2001. The jury awarded damages of $140.0 million against St. Jude. The Company did not record a gain given the uncertainty remaining as to the ultimate resolution. On February 13, 2002, the court, in ruling on a number of post-trial motions, reversed each of the three-jury findings above, along with the jury award. The court awarded St. Jude certain post-trial fees and costs (in an immaterial amount), along with contingent expenses and attorney fees upon any retrial of the case if a retrial is required following any appeal of the courts rulings. Cross appeals are pending in the Federal Circuit Court of Appeals.
Item 2. Changes in Securities, Use of Proceeds and Issuer Purchases of Equity Securities
The following table provides information about purchases by the Company during the quarter ended June 30, 2004, of the Companys common shares:
Period | Total Number of Shares Purchased (1) |
Average Price Per Share |
Total Number of Shares Purchased as Part of Publicly Announced Program |
Approximate Dollar Value of Shares That May Yet Be Purchased Under the Program | |||||
---|---|---|---|---|---|---|---|---|---|
04/01/04- | |||||||||
04/30/04 | 452,116 | $65.90 | 1,652,179 | $137,273,976 | |||||
05/01/04- | |||||||||
05/31/04 | -- | -- | 1,652,179 | $137,273,976 | |||||
06/01/04- | |||||||||
06/30/04 | -- | -- | 1,652,179 | $137,273,976 |
(1) | Guidant repurchased an aggregate of 452,116 common shares pursuant to the $250.0 million repurchase program publicly announced on February 17, 2004. |
Item 4. Submission of Matters to a Vote of Security Holders.
The Companys Annual Meeting of Shareholders was held on May 18, 2004. The following matters were voted on at the meeting:
Election of Directors:
Each of the following was elected to a three-year term to expire in 2007:
NAME | FOR | WITHHELD | |||
---|---|---|---|---|---|
Maurice A. Cox, Jr | 240,053,869 | 32,784,384 | |||
Nancy-Ann Min DeParle | 267,039,280 | 5,798,973 | |||
Ronald W. Dollens | 265,763,945 | 7,074,307 | |||
Enrique C. Falla | 240,206,957 | 32,631,296 | |||
Kristina M. Johnson, Ph.D | 268,749,715 | 4,088,537 |
Mr. Dollens, who also serves as President and Chief Executive Officer of the Company, has announced his intention to retire from that position at the end of the year. Ms. Susan B. King, a director of the Company from 1996 and member of the director class of 2005, passed away in July 2004.
Ratification of the appointment of Ernst & Young LLP as independent auditors for the year 2004:
For | 236,122,762 | ||
Against | 35,003,377 | ||
Abstain | 1,712,113 |
Shareholder proposal to adopt a policy regarding stock option expensing:
For | 153,034,896 | ||
Against | 87,060,595 | ||
Abstain | 4,971,637 | ||
Broker Non-Votes | 27,771,124 |
Thus, each listed director was elected to a three-year term, the appointment of auditors was ratified and the shareholder proposal received a majority of the votes cast (however not a majority of the shares outstanding).
The Companys board of directors is continuing to evaluate the advisory vote of the shareholders concerning stock option expensing, particularly in light of continuing developments in the area, including proposed rules from the Financial Accounting Standards Board as well as potentially inconsistent Congressional actions.
(a) | Exhibits. The Exhibit Index is incorporated herein by reference. |
(b) | Reports on Form 8-K. During the quarter for which this Report on Form 10-Q is filed, the Registrant filed two current reports on Form 8-K dated April 6, 2004 and April 22, 2004, describing pursuant to Item 12 the Companys earnings releases. |
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
GUIDANT CORPORATION (Registrant) |
|||||
Date: August 6, 2004 | /s/ Keith E. Brauer | ||||
Vice President, Finance and | |||||
Chief Financial Officer |
Date: August 6, 2004 | /s/ Peter J. Mariani | ||||
Vice President, Corporate | |||||
Controller and Chief Accounting Officer |
Exhibit 31.1: Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of Ronald W. Dollens
Exhibit 31.2: Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of Keith E. Brauer
Exhibit 32.1: Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of Ronald W. Dollens
Exhibit 32.2: Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of Keith E. Brauer
Exhibit 99: Factors Possibly Affecting Future Operating Results