PART I—FINANCIAL INFORMATION

 

Item 1.  Financial Statements

 

MEDTRONIC, INC.

CONDENSED STATEMENTS OF CONSOLIDATED EARNINGS

(Unaudited)

 

		Three months ended						Nine months ended
		January 28, 2005			January 23, 2004			January 28, 2005			January 23, 2004
		(in millions, except per share data)
Net sales		$	2,530.7		$	2,193.8		$	7,276.6		$	6,421.8
Costs and expenses:
Cost of products sold		605.6			538.4			1,740.7			1,588.4
Research and development expense		241.0			207.1			703.4			607.4
Selling, general and administrative expense		814.2			679.3			2,355.9			1,996.5
Purchased in-process research and development		—			22.0			—			23.9
Special charges		24.3			—			24.3			(4.8		)
Other expense, net		94.6			92.8			212.1			228.8
Interest income, net		(13.0		)	(3.6		)	(24.4		)	(1.1		)
Total costs and expenses		1,766.7			1,536.0			5,012.0			4,439.1
Earnings before income taxes		764.0			657.8			2,264.6			1,982.7
Provision for income taxes		219.9			193.9			655.1			592.3
Net earnings		$	544.1		$	463.9		$	1,609.5		$	1,390.4
Earnings per share:
Basic		$	0.45		$	0.38		$	1.33		$	1.14
Diluted		$	0.45		$	0.38		$	1.32		$	1.13
Weighted average shares outstanding:
Basic		1,208.2			1,211.8			1,208.9			1,214.8
Diluted		1,219.1			1,223.1			1,220.0			1,227.2

 

See accompanying notes to the condensed consolidated financial statements.

 

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MEDTRONIC, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

		January 28, 2005			April 30, 2004
		(in millions except per share data)
ASSETS
Current assets:
Cash and cash equivalents		$	2,185.5		$	1,593.7
Short-term investments		744.3			333.8
Accounts receivable, less allowances of $168.9 and $145.3, respectively		2,202.9			1,994.3
Inventories		1,014.5			877.7
Deferred tax assets, net		191.3			197.4
Prepaid expenses and other current assets		389.7			315.8
Total current assets		6,728.2			5,312.7
Property, plant and equipment		3,527.0			3,204.3
Accumulated depreciation		(1,722.4		)	(1,496.0		)
Net property, plant and equipment		1,804.6			1,708.3
Goodwill		4,277.8			4,236.9
Other intangible assets, net		1,042.6			999.3
Long-term investments		1,466.9			1,456.3
Other assets		375.3			397.3
Total assets		$	15,695.4		$	14,110.8
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Short-term borrowings		$	413.7		$	2,358.2
Accounts payable		344.8			346.2
Accrued compensation		454.5			459.8
Accrued income taxes		865.5			637.6
Other accrued expenses		577.4			438.8
Total current liabilities		2,655.9			4,240.6
Long-term debt		1,974.9			1.1
Deferred tax liabilities, net		442.0			408.2
Long-term accrued compensation		164.3			123.7
Other long-term liabilities		226.2			260.2
Total liabilities		5,463.3			5,033.8
Commitments and contingencies (Note 16)		—			—
Shareholders’ equity:
Preferred stock — par value $1.00		—			—
Common stock — par value $0.10		120.7			120.9
Retained earnings		9,974.7			8,890.9
Accumulated other non-owner changes in equity		138.9			72.0
		10,234.3			9,083.8
Receivable from employee stock ownership plan		(2.2		)	(6.8		)
Total shareholders’ equity		10,232.1			9,077.0
Total liabilities and shareholders’ equity		$	15,695.4		$	14,110.8

 

See accompanying notes to the condensed consolidated financial statements.

 

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MEDTRONIC, INC.

CONDENSED STATEMENTS OF CONSOLIDATED CASH FLOWS

(Unaudited)

 

		Nine months ended
		January 28, 2005			January 23, 2004
		(in millions)
OPERATING ACTIVITIES:
Net earnings		$	1,609.5		$	1,390.4
Adjustments to reconcile net earnings to net cash provided by operating activities:
Depreciation and amortization		339.3			332.6
Purchased in-process research and development		—			23.9
Special charges		24.3			(4.8		)
Tax benefit from exercise of stock options		52.0			—
Deferred income taxes		15.4			11.7
Change in operating assets and liabilities:
Accounts receivable		(135.8		)	(115.0		)
Inventories		(80.1		)	74.0
Accounts payable and accrued liabilities		240.6			139.4
Other operating assets and liabilities		(41.2		)	13.4
Net cash provided by operating activities		2,024.0			1,865.6
INVESTING ACTIVITIES:
Acquisitions, net of cash acquired		(96.4		)	(30.9		)
Additions to property, plant and equipment		(306.7		)	(285.1		)
Purchases of marketable securities		(996.8		)	(1,915.6		)
Sales and maturities of marketable securities		532.8			804.5
Other investing activities, net		76.3			123.5
Net cash used in investing activities		(790.8		)	(1,303.6		)
FINANCING ACTIVITIES:
Increase in short-term borrowings, net		21.9			89.2
Decrease in long-term debt, net		—			(4.7		)
Dividends to shareholders		(303.6		)	(263.9		)
Issuance of common stock		236.7			177.0
Repurchase of common stock		(511.0		)	(668.6		)
Net cash used in financing activities		(556.0		)	(671.0		)
Effect of exchange rate changes on cash and cash equivalents		(85.4		)	(93.6		)
Net change in cash and cash equivalents		591.8			(202.6		)
Cash and cash equivalents at beginning of period		1,593.7			1,470.1
Cash and cash equivalents at end of period		$	2,185.5		$	1,267.5
Supplemental Noncash Investing and Financing Activities:
Issuance of common stock in connection with an acquisition		$	—		$	57.5
Reclassification of debentures from long-term to short-term debt		$	—		$	1,973.8
Reclassification of debentures from short-term to long-term debt		$	1,973.2		$	—

 

See accompanying notes to the condensed consolidated financial statements.

 

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MEDTRONIC, INC

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Note 1 — Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S.) 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 necessary for a fair presentation of results of operations, financial position, and cash flows in conformity with accounting principles generally accepted in the U.S. In the opinion of management, the condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the results of Medtronic, Inc. and its subsidiaries (Medtronic or the Company) for the periods presented. Operating results for interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole. The preparation of the financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and the related disclosures at the date of the financial statements and during the reporting period. Actual results could materially differ from these estimates.  For further information, refer to the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended April 30, 2004.

 

Note 2 — Stock-Based Compensation

 

The Company accounts for stock-based employee compensation using the intrinsic value method as prescribed under Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees” and related Interpretations.  Accordingly, the Company would record compensation expense if the quoted market price on the date of grant exceeds the exercise price.  Compensation expense for stock options is calculated as the number of options granted multiplied by the amount the market price exceeds the exercise price.  For options with a vesting period, the expense, if applicable, is recognized over the vesting period.  Compensation expense is recognized immediately for options that are fully vested on the date of grant.  The Company has not recognized any stock option related employee compensation expense during the three and nine months ended January 28, 2005 and January 23, 2004.

 

If the Company had elected to recognize compensation expense for its employee stock-based compensation plans based on the fair values at the grant dates, consistent with the methodology prescribed by Statement of Financial Accounting Standards (SFAS) No. 123, “Accounting for Stock-Based Compensation,” net earnings and earnings per share would have been reported as follows (in millions, except per share data):

 

		Three months ended						Nine months ended
		January 28, 2005			January 23, 2004			January 28, 2005			January 23, 2004
Net Earnings:
As reported		$	544.1		$	463.9		$	1,609.5		$	1,390.4
Additional compensation cost under the fair value method (1)		37.9			41.1			172.3			126.5
Pro forma		$	506.2		$	422.8		$	1,437.2		$	1,263.9
Basic Earnings Per Share:
As reported		$	0.45		$	0.38		$	1.33		$	1.14
Pro forma		0.42			0.35			1.19			1.04
Diluted Earnings Per Share:
As reported		$	0.45		$	0.38		$	1.32		$	1.13
Pro forma		0.42			0.35			1.18			1.03

 

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(1) Additional compensation cost under the fair value method is net of related tax effects.

 

In response to numerous external factors, including rising medical benefit costs and evolving workforce demographics, the Company completed an extensive study to realign its portfolio of employee benefits.  As a result of this study and the planned changes to employee benefits, including the cessation of the Employee Stock Ownership Plan contribution at the end of fiscal year 2005 and changes to both the U.S. defined benefit pension and post-retirement medical plans, the Company awarded fully vested, nonqualified stock options to eligible employees as part of its annual broad employee-based stock option award, which took place during the second quarter of fiscal year 2005.  Due to the immediate vesting provisions, this one-time award, with an aggregate fair value, net of tax, of $64.2 million, resulted in increased pro forma compensation expense for the nine months ended January 28, 2005 as compared to the typical grant that is expensed over a four-year vesting period.  Executive officers who received stock options in connection with the annual grant did not receive fully vested awards, but instead received awards subject to the Company’s standard policy on option vesting, which is generally over a four-year period.  The actual number of total employee stock option grants remains consistent with prior years.

 

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For purposes of the pro forma disclosures, the weighted average fair values per stock option granted for the three and nine months ended January 28, 2005 were $13.69 and $8.46, respectively, and for the three and nine months ended January 23, 2004 were $ 12.25 and $11.89 , respectively.  The lower fair value per stock option granted for the nine months ended January 28, 2005 resulted from the fully vested stock option award mentioned previously.  To determine the expected option term of the fully vested options, the Company performed an analysis on the average holding period of options from the vesting date to the exercise date.  The fair values were estimated using the Black-Scholes option-pricing model using the following weighted average assumptions:

 

		Three months ended				Nine months ended
		January 28, 2005		January 23, 2004		January 28, 2005		January 23, 2004
Assumptions
Risk-free interest rate		3.66	%	3.24	%	3.33	%	3.14	%
Expected dividend yield		0.66	%	0.60	%	0.67	%	0.62	%
Annual volatility factor		25.0	%	23.5	%	22.5	%	24.0	%
Expected option term		5 years		5 years		3 years		5 years

 

Note 3 — New Accounting Pronouncements

 

In November 2003 and March 2004, the Emerging Issues Task Force (EITF) reached a consensus on Issue No. 03-1, “The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments.” The consensus reached requires companies to apply new guidance for evaluating whether an investment is other-than-temporarily impaired and also requires quantitative and qualitative disclosure of debt and equity securities, classified as available-for-sale or held-to-maturity, that are determined to be only temporarily impaired at the balance sheet date. The Company incorporated the required disclosures for investments accounted for under SFAS No. 115, “Accounting for Certain Investments in Debt and Equity Securities,” as required in the fourth quarter of fiscal year 2004.  In September 2004, the adoption date of the consensus was indefinitely delayed as it relates to the measurement and recognition of impairment losses for all securities in the scope of paragraphs 10-20 of Issue No. 03-1.  The disclosures prescribed by Issue No. 03-1 and guidance related to impairment measurement prior to the issuance of this consensus continue to remain in effect.  Adoption is not expected to have a material impact on the Company’s consolidated earnings, financial position or cash flows.

 

In December 2003, the Financial Accounting Standards Board (FASB) issued SFAS No. 132(R) “Employers’ Disclosures about Pensions and Other Post-retirement Benefits.” This standard increases the existing disclosure requirements by requiring more details about pension plan assets, benefit obligations, cash flows, benefit costs and related information. The expanded disclosures require that plan assets be segregated by category, such as debt, equity and real estate, and that disclosures on certain expected rates of return be incorporated. SFAS No. 132(R) will also require the Company to disclose various elements of pension and post-retirement benefit costs in interim-period financial statements. The Company adopted SFAS No. 132(R) for the Company’s U.S. plans in the fourth quarter of fiscal year 2004, resulting in additional disclosures in all interim and annual reporting periods.  The statement is effective for the Company’s plans outside the U.S. starting in the fourth quarter of fiscal year 2005. Adoption of the statement’s increased disclosures will not have an impact on the Company’s consolidated earnings, financial position or cash flows.

 

In September 2004, the EITF reached a consensus regarding Issue No. 04-8, “The Effect of Contingently Convertible Instruments on Diluted Earnings Per Share,” requiring that the dilutive effect of contingent convertible debt instruments (CoCos) be included in diluted earnings per share calculations for all periods (if dilutive), regardless of whether the triggering contingency has been satisfied.  Adoption of Issue No. 04-8 requires retroactive restatement of prior period dilutive earnings per share for CoCos outstanding at the implementation date.  The consensus was effective for the Company in the third quarter of fiscal year 2005.  At the date of adoption, the Company had two series of contingently convertible debentures outstanding, including approximately $45 million in principal amount of 1.25 percent Contingent Convertible Debentures (Old Debentures) and approximately $1,928 million in principal amount of 1.25 percent Contingent Convertible Debentures, Series B (New Debentures).  As a result of adoption, the Company has included an additional 727,358 shares, related to the assumed conversion of the Old Debentures, in its computation of diluted earnings per share for the three and nine months ended January 28, 2005 (see Note 9 for discussion of the CoCos).  As required, diluted shares outstanding and diluted earnings per share for the three and nine months ended January 23, 2004 were also restated to include these shares.  However, the inclusion of the shares issuable upon conversion of the CoCos did not impact diluted earning per share as previously reported.  T he potentially dilutive common shares related to the New Debentures would only be included in the diluted earnings per share calculation at such time in the future when the Company’s stock price rises above the conversion price.  The dilutive impact would be equal to the number of shares needed to satisfy the “in-the-money” value of the New Debentures, assuming conversion.  The adoption of this consensus did not have a material impact on diluted earnings per share for the three and nine months ended January 28, 2005 and January 23, 2004.

 

In September 2004, the EITF reached a consensus on Issue No. 04-1 “Accounting for Preexisting Relationships between the Parties to a Business Combination,” which requires that preexisting relationships between two parties of a business combination be settled prior to the combination.  The EITF also addresses the measurement and recognition of settlements related to preexisting receivables and payables, executory contracts, intangible asset rights, and gain settlements among the parties to a business combination.  This consensus was effective for the Company in the third quarter of fiscal year 2005.  Adoption did not have a material impact on the Company’s consolidated earnings, financial position or cash flows.

 

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In September 2004, the EITF reached a consensus on Issue No. 04-10, “Applying Paragraph 19 of FASB Statement No. 131, Disclosures about Segments of an Enterprise and Related Information (SFAS No. 131), in Determining Whether to Aggregate Operating Segments That Do Not Meet the Quantitative Thresholds.”  Issue No. 04-10 clarifies the criteria for aggregating an operating segment that does not meet all of the aggregation criteria in paragraph 17 of SFAS No. 131, but also falls below the quantitative criteria that would dictate that the segment be reported separately.  The consensus reached would enable an entity to aggregate two or more segments that have similar economic characteristics and share a majority of the aggregation criteria in paragraph 17 of SFAS No. 131.  Although Issue No. 04-10 was to be effective immediately, in November 2004 the EITF delayed the implementation of this issue in order to have its effective date coincide with a related FASB Staff Position (FSP), which will clarify the meaning of similar economic characteristics.  Issue No. 04-10 is to be applied by retroactive restatement of previous periods.  Adoption of Issue No. 04-10 is not expected to have an impact on the Company’s consolidated earnings, financial position or cash flows.

 

In November 2004, the FASB issued SFAS No. 151, “Inventory Costs, an amendment of Accounting Research Bulletin No. 43, Chapter 4,” which adopts wording from the International Accounting Standards Board’s (IASB) IAS 2 “Inventories” in an effort to improve the comparability of cross-border financial reporting.  The FASB and IASB both believe the standards have the same intent; however, an amendment to the wording was adopted to avoid inconsistent application.  The new standard indicates that abnormal freight, handling costs, and wasted materials (spoilage) are required to be treated as current period charges rather than as a portion of inventory cost.  Additionally, the standard clarifies that fixed production overhead should be allocated based on the normal capacity of a production facility.  The Statement is effective for the Company beginning in fiscal year 2007.  Adoption is not expected to have a material impact on the Company’s consolidated earnings, financial position or cash flows.

 

In December 2004, the FASB issued SFAS 123(R), “Share-Based Payment.” This Statement is a revision to SFAS 123, “Accounting for Stock-Based Compensation,” and supersedes APB Opinion No. 25, “Accounting for Stock Issued to Employees.”  SFAS 123(R) requires the recognition of the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award.  The cost will be recognized over the period during which an employee is required to provide service in exchange for the award.  No compensation cost is recognized for equity instruments for which employees do not render the required service period.  The Statement is effective for the Company beginning in the second quarter of fiscal year 2006.  Based on unvested stock options currently outstanding, the expense associated with the employee stock purchase plan (ESPP) and anticipated fiscal year 2006 grants, the effect of adopting SFAS 123(R) is expected to reduce the Company’s net income by $95 - $110 million in the final three quarters of fiscal year 2006.

 

In December 2004, the FASB issued SFAS No. 153, “Exchanges of Nonmonetary Assets.” The Statement is an amendment of APB Opinion No. 29 and eliminates the exception that non-monetary exchanges of similar productive assets be recorded at the value of the assets relinquished, rather than fair value.  Under SFAS No. 153, the exception to recognition of the exchange at fair value is instead reserved for exchanges of non-monetary assets that do not have commercial substance. The Statement is effective for the Company beginning in the first quarter of fiscal year 2006.  Adoption is not expected to have a material impact on the Company’s consolidated earnings, financial position or cash flows.

 

In December 2004, the FASB issued FSP FAS 109-1, “Application of FASB Statement No. 109, Accounting for Income Taxes, to the Tax Deduction on Qualified Production Activities Provided by the American Jobs Creation Act of 2004.” The FSP clarifies that the manufacturer’s deduction provided for under the American Jobs Creation Act of 2004 (the Act) should be accounted for as a special deduction in accordance with SFAS No. 109, “Accounting for Income Taxes,” and not as a tax rate reduction. The Qualified Production Activities Deduction will not impact the Company’s consolidated earnings, financial position or cash flows for fiscal year 2005 because the deduction is not available to the Company until fiscal year 2006. The Company is currently evaluating the effect that this deduction will have in subsequent years.

 

In December 2004, the FASB issued FSP FAS 109-2, “Accounting and Disclosure Guidance for the Foreign Earnings Repatriation Provision within the American Jobs Creation Act of 2004.” The Act, signed into law on October 22, 2004, provides for a special one-time tax deduction of 85 percent of certain cash dividends received from controlled foreign corporations.  The deduction is available to corporations during the tax year that includes Octbober 22, 2004 or in the immediately subsequent tax year.  The FSP allows a company additional time, beyond the financial reporting period of enactment, to evaluate the effects of the Act on their plans for repatriation of foreign earnings for purposes of applying SFAS 109, “Accounting for Income Taxes.”  See Note 13 for further details on the Act and its impact to the Company.

 

Note 4 – Acquisitions

 

During the third quarter of fiscal year 2005, the Company acquired all of the outstanding stock of Angiolink Corporation (Angiolink), a privately held company that developed wound closure devices for vascular procedures.  Angiolink’s EVS ^TM  Vascular Closure system, which has received U.S. Food and Drug Administration (FDA) approval, is engineered to close the femoral artery access site after vascular procedures, such as diagnostic angiography, balloon angioplasty and stenting.  The EVS system provides safe and effective mechanical closure of arterial puncture sites without disturbing the lumen, or interior, of the targeted vessel.  This acquisition provides the Company an additional vascular closure offering to the current closure product – the non-invasive Clo-Sur P.A.D. ^TM .  The net consideration paid for Angiolink was approximately $42.3 million in cash subject to purchase price increases, which

 

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would be triggered by the achievement of certain milestones. The net cash purchase price of $42.3 million is a product of the $45.2 million purchase price, including direct acquisition costs, less $2.9 million of acquired cash.

 

In connection with the acquisition of Angiolink, the Company acquired $62.5 million of technology-based intangible assets that have an estimated useful life of 12 years and $11.2 million in goodwill.  The goodwill was assigned entirely to the Vascular operating segment and is not deductible for tax purposes.

 

The following table summarizes the preliminary allocation of the Angiolink purchase price to the estimated fair values of the assets acquired and liabilities assumed (in millions):

 

Current assets		$	3.1
Property, plant and equipment		0.6
Other intangible assets, net		62.5
Goodwill		11.2
Deferred tax asset—long term		5.0
Total assets acquired		82.4
Current liabilities		2.8
Deferred tax liability – long term		34.4
Total liabilities assumed		37.2
Net assets acquired		$	45.2

 

During the second quarter of fiscal year 2005, the Company acquired substantially all of the assets of Coalescent Surgical, Inc. (Coalescent).   Coalescent developed the U-Clip™ Anastomotic Device and the SPYDER ™ Proximal Anastomotic Device.  The U-Clip device creates high-quality anastomoses (a seamless connection) without sutures and is primarily used in coronary artery bypass surgery.   The SPYDER device automatically deploys a series of U-Clip devices when attaching the bypass graft to the aorta.  This acquisition is expected to complement the Company’s surgical product line and strategy to develop technologies to promote surgical procedures that produce better patient outcomes, and reduce trauma and hospitalization.  The consideration paid for Coalescent was approximately $54.1 million in cash subject to purchase price increases, which would be triggered by the achievement of certain milestones.

 

In connection with the acquisition of Coalescent, the Company acquired $42.2 million of technology-based intangible assets that have an estimated useful life of 12 years, and $1.5 million of other intangible assets with an estimated useful life of 5 years.  Goodwill of $7.0 million related to the acquisition was assigned entirely to the Cardiac Surgery operating segment.  This goodwill is deductible for tax purposes.

 

The following table summarizes the preliminary allocation of the Coalescent purchase price to the estimated fair values of the assets acquired and liabilities assumed (in millions):

 

Current assets		$	2.6
Property, plant and equipment		1.3
Other intangible assets, net		43.7
Goodwill		7.0
Total assets acquired		54.6
Current liabilities		0.5
Total liabilities assumed		0.5
Net assets acquired		$	54.1

 

The pro forma impact of the Angiolink and Coalescent acquisitions was not significant, individually or in the aggregate, to the results of operations of the Company for the three and nine months ended January 28, 2005.

 

In the third quarter of fiscal year 2004, the Company acquired all of the outstanding stock of Vertelink Corporation (Vertelink).  Vertelink was a privately held development stage company that developed materials and techniques for “over-the-wire” spinal fixation devices that can achieve multi-level stabilization of the cervical, thoracic and lumbar spine. Key Vertelink products included the KOBRA ^TM Fixation System and the SST ^TM Spinal Fixation System.  Both systems permit surgeons to place spinal instrumentation utilizing tissue-sparing, minimally invasive methods.  At the time of the acquisition, the KOBRA system was being reviewed for 510(k) approval by the FDA, which was subsequently obtained during the third quarter of fiscal year 2004.  The Company expects that the SST System will obtain CE Mark to support European release within the next twelve months.   Vertelink’s products enhance the strategic initiative of Medtronic’s Spinal business that focuses on Minimal Access Spinal Technologies (MAST).  The

 

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consideration paid was approximately $22.1 million in cash subject to purchase price increases, which would be triggered by the achievement of certain milestones.  In connection with the acquisition the Company allocated $22.0 million of the purchase price to purchased in-process research and development (IPR&D), which was expensed on the date of the acquisition, and allocated the remaining amount to property and equipment and other intangible assets (see Note 5).  In the third quarter of fiscal year 2005, Vertelink obtained FDA approval on the next generation KOBRA system, thereby attaining one of the milestones in the original purchase agreement.  As a result of attaining that milestone, the Company paid an additional $2.0 million in consideration, which was allocated between technology-based intangible assets of $3.3 million and an offsetting long-term deferred tax liability of $1.3 million.

 

In the third quarter of fiscal year 2004, the Company acquired certain assets of Radius Medical Inc. (Radius), which was accounted for as a purchase of assets.  Radius was a privately held corporation specializing in the research, development and manufacture of interventional guidewires and related products for the cardiovascular marketplace.  The assets acquired from Radius broaden and enhance the Company’s existing guidewire product and technology portfolio.  The consideration paid was $5.1 million subject to purchase price increases, which would be triggered by the achievement of certain milestones. The $5.1 million purchase price was allocated to intangible assets.

 

During the third quarter of fiscal year 2004, the Company also acquired substantially all of the assets of Premier Tool, Inc. (Premier Tool).  Premier Tool was a privately held corporation engaged in the engineering and manufacturing of metal instruments used to implant spinal devices. The assets acquired enhance Medtronic’s current line of spinal instrumentation products.  The consideration paid was approximately $4.0 million.  The purchase price was allocated primarily to other intangible assets and property and equipment, with the remainder allocated to goodwill, which was assigned entirely to the Spinal operating segment.

 

In the second quarter of fiscal year 2004, the Company acquired substantially all of the assets of TransVascular, Inc. (TVI).  Prior to the acquisition, the Company had a minority investment in TVI, which was accounted for under the cost method of accounting.  TVI developed and marketed the Pioneer Catheter™ (formerly the CrossPoint® TransAccess ® Catheter System), a proprietary delivery technology for several current and potential intravascular procedures, such as the potential ability to deliver therapeutic agents, including cells, genes, and drugs to precise locations within the vascular system.  The Pioneer Catheter received FDA 510(k) clearance in fiscal year 2002 and is indicated to facilitate the positioning and placement of catheters within the peripheral vasculature.  This strategic acquisition complements Medtronic’s current commitment to advance therapies and treatments by combining biologic and device therapies.

 

The consideration paid for TVI was approximately $58.7 million subject to purchase price increases, which would be triggered by the achievement of certain milestones.  The initial consideration included the issuance of approximately 1.2 million shares of Medtronic common stock valued at $57.5 million, the Company’s prior investment in TVI and acquisition-related costs.  The Medtronic common shares issued in connection with the TVI acqusition were valued based on the average of Medtronic’s trading share prices several days before and after the date when the trading share prices became known.

 

In connection with the acquisition of TVI, the Company acquired $27.3 million of technology-based intangible assets that have an estimated useful life of 15 years and $1.9 million of IPR&D that was expensed on the date of acquisition  (See Note 5).  Goodwill of $31.9 million related to the acquisition was assigned entirely to the Vascular operating segment.  This goodwill is not deductible for tax purposes.

 

The following table summarizes the allocation of the TVI purchase price to the estimated fair values of the assets acquired and liabilities assumed (in millions):

 

Current assets		$	0.6
Property, plant and equipment		0.1
Other intangible assets, net		27.3
IPR&D		1.9
Goodwill		31.9
Deferred tax asset—long term		8.4
Total assets acquired		70.2
Current liabilities		0.6
Deferred tax liability—long term		10.9
Total liabilities assumed		11.5
Net assets acquired		$	58.7

 

The pro forma impact of the results of the Radius, Premier Tool, Vertelink and TVI acquisitions was not significant, individually or in the aggregate, to the results of operations the Company for the three and nine months ended January 23, 2004.

 

9

 

Note 5 — Special and IPR&D Charges

 

Special charges (such as certain litigation and restructuring charges) and IPR&D charges result from unique facts and circumstances that may or may not recur with similar materiality or impact on continuing operations.

 

Special Charges:

 

The Company recorded a $24.3 million special charge for the three and nine months ended January 28, 2005 related to the judgment entered by the court in the DePuy/AcroMed, Inc. (DePuy/AcroMed) case for damages, including prejudgment interest.  The judgment results from a patent infringement case regarding the design of the thoracolumbar multiaxial screw previously sold by Medtronic Sofamor Danek, Inc. (MSD) in the U.S. market. See additional discussion of this case in Note 16.

 

There were no special charges for the three months ended January 23, 2004.  Special charges for the nine months ended January 23, 2004 consisted of a $4.8 million reversal related to the Vascular facility consolidation initiatives, which started in the first quarter of fiscal year 2003.  The $4.8 million change in estimate was a result of the following favorable outcomes in the execution of these initiatives: a decrease of $2.4 million as a result of selling or utilizing existing assets which were previously identified for impairment; a decrease of $1.8 million related to subleasing a facility earlier than anticipated; and a decrease of $0.6 million in severance payments related to employees identified for elimination who found positions elsewhere in the Company.

 

IPR&D:

 

There were no IPR&D charges for the three and nine months ended January 28, 2005.  During the third quarter of fiscal year 2004, the Company acquired Vertelink.  At the date of the acquisition, $22.0 million of the purchase price was expensed for IPR&D related to spinal fixation devices that had not yet reached technological feasibility and had no future alternative use.   One of these devices, the KOBRA Fixation System, has since received FDA approval.   The technology will be adapted for use in manufacturing spinal fixation devices that can achieve multi-level stabilization of the cervical, thoracic and lumbar spine.   Prior to the acquisition, Medtronic did not have a comparable product under development.  The Company expects to incur costs totaling $1.1 million in fiscal year 2005, $1.0 million in fiscal year 2006, and $0.6 million in fiscal year 2007 to bring these products to commercialization in the U.S.  These costs will be funded by internally generated cash flows.

 

During the second quarter of fiscal year 2004, the Company acquired TVI.  At the date of acquisition, $1.9 million of the purchase price was expensed for IPR&D related to a cell and agent delivery device that had not yet reached technological feasibility and had no future alternative use.  This delivery device will be adapted for use in the percutaneous delivery of cells, genes, and drugs to specific tissues.  Prior to the acquisition, Medtronic did not have a comparable product under development.  The Company expects to incur costs totaling $3.6 million in fiscal year 2005, $4.6 million in fiscal year 2006, $4.8 million in fiscal year 2007, $6.0 million in fiscal year 2008, and $6.0 million in fiscal year 2009 to bring this product to commercialization in the U.S.  These costs will be funded by internally generated cash flows.

 

The Company is responsible for the valuation of IPR&D charges.  The values assigned to IPR&D are based on valuations that have been prepared using methodologies and valuation techniques consistent with those used by independent appraisers.  All values were determined by identifying research projects in areas for which technological feasibility had not been established.  Additionally, the values were determined by estimating the revenue and expenses associated with a project’s sales cycle and the amount of after-tax cash flows attributable to these projects.  The future cash flows were discounted to present value utilizing an appropriate risk-adjusted rate of return.  The rate of return included a factor that takes into account the uncertainty surrounding the successful development of the IPR&D.

 

At the time of acquisition, the Company expects all acquired IPR&D will reach technological feasibility, but there can be no assurance that the commercial viability of these products will actually be achieved. The nature of the efforts to develop the acquired technologies into commercially viable products consists principally of planning, designing and conducting clinical trials necessary to obtain regulatory approvals.  The risks associated with achieving commercialization include, but are not limited to, delay or failure to obtain regulatory approvals to conduct clinical trials, delay or failure to obtain required market clearances, and patent litigation. If commercial viability were not achieved, the Company would likely look to other alternatives to provide these therapies.

 

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Note 6 — Inventories

 

Inventories are stated at the lower of cost or market, with cost determined on a first-in, first-out basis.  Inventory balances are as follows (in millions):

 

		January 28, 2005			April 30, 2004
Finished goods		$	638.7		$	541.4
Work in process		147.2			140.1
Raw materials		228.6			196.2
Total		$	1,014.5		$	877.7

 

Note 7 — Goodwill and Other Intangible Assets

 

The changes in the carrying amount of goodwill for the nine months ended January 28, 2005 are as follows (in millions):

 

		January 28, 2005
Balance at April 30, 2004		$	4,236.9
Goodwill as a result of acquisitions		19.8
Currency adjustment, net		21.1
Balance at January 28, 2005		$	4,277.8

 

Intangible assets, excluding goodwill, as of January 28, 2005 and April 30, 2004 are as follows (in millions):

 

		Purchased Technology and Patents			Trademarks and Tradenames			Other			Total
As of January 28, 2005:
Amortizable intangible assets
Original cost		$	1,012.3		$	264.7		$	257.6		$	1,534.6
Accumulated amortization		(299.7		)	(90.4		)	(101.9		)	(492.0		)
Carrying value		$	712.6		$	174.3		$	155.7		$	1,042.6
As of April 30, 2004:
Amortizable intangible assets
Original cost		$	901.9		$	264.7		$	224.8		$	1,391.4
Accumulated amortization		(245.0		)	(70.6		)	(76.5		)	(392.1		)
Carrying value		$	656.9		$	194.1		$	148.3		$	999.3

 

Amortization expense for the three and nine months ended January 28, 2005 was approximately $33.0 million and $93.8 million, respectively, and for the three and nine months ended January 23, 2004 was approximately $29.7 million and $86.6 million , respectively.

 

Note 8 — Warranty Obligation

 

The Company offers a warranty on various products.  The Company estimates the costs that may be incurred under its warranties and records a liability in the amount of such costs at the time the product is sold.  Factors that affect the Company’s warranty liability include the number of units sold, historical and anticipated rates of warranty claims, and cost per claim.  The Company periodically assesses the adequacy of its recorded warranty liabilities and adjusts the amounts as necessary.  The amount of the reserve recorded is equal to the costs to repair or otherwise satisfy the claim.  The Company recorded $6.1 million and $ 3.9 million of warranty expense for the three month periods ended January 28, 2005 and January 23, 2004, respectively, and $11.6 million and $8.7 million of warranty expense for the nine month periods ended January 28, 2005 and January 23, 2004, respectively.  The warranty accrual as of January 28, 2005 and April 30, 2004 was $29.1 million and $35.5 million, respectively.

 

Note 9 – Contingent Convertible Debentures

 

In September 2001, the Company completed a $2,013 million private placement of 1.25 percent Contingent Convertible Debentures due September 2021 (Old Debentures). Interest is payable semi-annually and accrues at 1.25% per annum.  Each Old Debenture is convertible into shares of common stock at an initial conversion price of $61.81 per share; however, the shares are not convertible until the closing price of the

 

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Company’s common stock reaches 110% of the conversion price for 20 trading days during a consecutive 30 trading day period.  The conversion price of the Old Debentures will be adjusted based on the occurrence of specified events, including a stock split, stock dividend, or cash dividend exceeding 15% of the Company’s market capitalization.

 

In September 2002 and 2004, as a result of certain holders of the Old Debentures exercising their put options, the Company repurchased $39 million, or 1.9%, and $0.6 million, or 0.03%, respectively, of the Old Debentures for cash.  The Company may be required to repurchase the remaining securities at the option of the holders in September 2006, 2008, 2011 or 2016.  Twelve months prior to the put options becoming exercisable, the remaining balance of the contingent convertible debentures will be classified as short-term borrowings .  At each balance sheet date without a put option within the subsequent four quarters, the remaining balance will be classified as long-term debt .  For put options exercised by the holders, the purchase price is equal to the principal amount of the Old Debentures plus any accrued and unpaid interest on the Old Debentures to the repurchase date.  If the repurchase option is exercised, the Company may elect to repurchase the Old Debentures with cash, common stock, or some combination thereof.  The Company may elect to redeem the Old Debentures for cash at any time after September 2006.

 

On January 24, 2005, the Company completed an exchange offer on its contingent convertible debentures, whereby holders of approximately 97.7% of the total principal amount of our Old Debentures exchanged their existing securities for an equal principal amount of 1.25 percent Contingent Convertible Debentures, Series B due 2021 (New Debentures), and an exchange fee of $2.50 per $1,000 principal amount.  The terms of the New Debentures are consistent with the terms of the Old Debentures noted above, except that: (i) upon conversion, the Company will pay holders cash equal to the lesser of the principal amount of the New Debentures or their conversion value, and shares of its common stock to the extent the conversion value exceeds the principal amount; and (ii) the New Debentures will require the Company to pay only cash (in lieu of shares of its common stock or a combination of cash and shares of its common stock) when the Company repurchases the New Debentures at the option of the holder or in connection with a change of control.   Following the completion of the exchange offer, approximately $45 million aggregate principal amount of Old Debentures and $1,928 million aggregate principal amount of New Debentures remain outstanding.  The fee paid to the holders of the New Debentures was capitalized and will be amortized over the twenty month period ending in September 2006.

 

Note 10 — Comprehensive Income and Accumulated Other Non-Owner Changes in Equity

 

In addition to net earnings, comprehensive income includes changes in foreign currency translation adjustments (including the change in current exchange rates, or spot rates, of net investment hedges), unrealized gains and losses on foreign exchange derivative contracts qualifying and designated as cash flow hedges, minimum pension liabilities, and unrealized gains and losses on available-for-sale marketable securities. Comprehensive income for the three months ended January 28, 2005 and January 23, 2004 was $539.9 million and $514.0 million, respectively.  Comprehensive income for the nine months ended January 28, 2005 and January 23, 2004 was $1,676.4 million and $1,474.2 million, respectively.

 

Presented below is a summary of activity for each component of accumulated other non-owner changes in equity (in millions):

 

		Cumulative Translation Adjustment			Unrealized Gain (Loss) on Foreign Exchange Derivatives			Minimum Pension Liability			Unrealized Gain (Loss) on Investments			Accumulated Other Non-Owner Changes in Equity
Balance April 30, 2004		$	128.1		$	(47.0	)	$	(10.3	)	$	1.2		$	72.0
Period Change		10.6			8.5			(0.5		)	(5.0		)	13.6
Balance July 30, 2004		138.7			(38.5		)	(10.8		)	(3.8		)	85.6
Period Change		46.7			1.7			(0.3		)	9.4			57.5
Balance October 29, 2004		185.4			(36.8		)	(11.1		)	5.6			143.1
Period Change		14.3			(0.4		)	(0.1		)	(18.0		)	(4.2		)
Balance January 28, 2005		$	199.7		$	(37.2	)	$	(11.2	)	$	(12.4	)	$	138.9

 

Translation adjustments are not adjusted for income taxes as substantially all translation adjustments relate to our non-U.S. subsidiaries, which are considered permanent in nature.  The tax expense on the unrealized loss on derivatives for the three months ended January 28, 2005 was $5.7 million and the tax expense on the unrealized gain on derivatives for the nine months ended January 28, 2005 was $7.1 million.  The tax benefit on the minimum pension liability was not material for the three and nine months ended January 28, 2005.  The tax benefit on the unrealized loss on investments for the three and nine months ended January 28, 2005 was $9.7 million and $7.4 million, respectively.

 

Note 11 — Retirement Benefit Plans

 

The Company sponsors various retirement benefit plans, including defined benefit pension plans (pension benefits), defined contribution savings plans, post-retirement medical plans (other benefits), and termination indemnity plans, covering substantially all U.S. employees and many employees outside the U.S.  The net periodic benefit cost of the pension and post-retirement medical plans

 

12

 

include the following components for the three and nine months ended January 28, 2005 and January 23, 2004 (in millions):

 

		Qualified Pension Benefits Three months ended						Non-qualified Pension Benefits Three months ended						Other Benefits Three months ended
		January 28, 2005			January 23, 2004			January 28, 2005			January 23, 2004			January 28, 2005			January 23, 2004
Service cost		$	14.3		$	11.0		$	0.8		$	0.6		$	3.0		$	2.3
Interest cost		10.0			7.7			0.7			0.5			2.6			2.0
Expected return on plan assets		(15.3		)	(11.9		)	—			—			(1.5		)	(1.0		)
Amortization of prior service cost		3.2			1.7			0.1			(0.1		)	1.2			1.0
Net periodic benefit cost		$	12.2		$	8.5		$	1.6		$	1.0		$	5.3		$	4.3

 

		Qualified Pension Benefits Nine months ended						Non-qualified Pension Benefits Nine months ended						Other Benefits Nine months ended
		January 28, 2005			January 23, 2004			January 28, 2005			January 23, 2004			January 28, 2005			January 23, 2004
Service cost		$	42.9		$	33.0		$	2.4		$	1.8		$	9.0		$	6.9
Interest cost		30.0			23.1			2.1			1.5			7.8			6.0
Expected return on plan assets		(45.9		)	(35.7		)	—			—			(4.5		)	(3.0		)
Amortization of prior service cost		9.6			5.1			0.3			(0.3		)	3.6			3.0
Net periodic benefit cost		$	36.6		$	25.5		$	4.8		$	3.0		$	15.9		$	12.9

 

In April 2004, the FASB issued FSP 106-2, “Accounting and Disclosure Requirements Related to the Medicare Prescription Drug, Improvement and Modernization Act of 2003” (MMA).  The FSP requires companies to assess the effect of MMA on their retirement-related benefit costs and obligations and reflect the effects in the financial statements, pursuant to SFAS 106, “Employer’s Accounting for Post-retirement Benefits Other Than Pensions.”  On January 21, 2005, the Centers for Medicare and Medicaid Services (CMS) released the final regulations (the “Regulations”) for the implementation of the MMA.  As a result of these Regulations, the Company has determined that the benefits provided under its plan are actuarially equivalent to the benefits provided under Part D of the MMA.  The Company will recognize the effect of the MMA in its January 31, 2005 measurement date; however, given the timing of the Regulations, the MMA will not have an impact on the fiscal year 2005 net periodic benefit cost.  Upon implementation of the MMA, the Company estimates that the accumulated post-retirement obligation will be reduced between $13 - 23 million as of April 29, 2005 and the net periodic benefit cost for fiscal year 2006 will be reduced by $2 - $4 million.

 

Note 12 — Interest (Income)/Expense

 

Interest income and interest expense for the three and nine month periods ended January 28, 2005 and January 23, 2004 are as follows (in millions):

 

		Three months ended						Nine months ended
		January 28, 2005			January 23, 2004			January 28, 2005			January 23, 2004
Interest income		$	(25.9	)	$	(18.0	)	$	(64.3	)	$	(40.2	)
Interest expense		12.9			14.4			39.9			39.1
Interest income, net		$	(13.0	)	$	(3.6	)	$	(24.4	)	$	(1.1	)

 

Note 13 — Income Taxes

 

The provision for income taxes consists of provisions for federal, state and foreign income taxes.  The Company operates in an international environment with significant operations in various locations outside the U.S.  Accordingly, the consolidated income tax rate is a composite rate reflecting the earnings in the various locations and the applicable rates.

 

On October 22, 2004, the American Jobs Creation Act of 2004 (the Act) was signed into law by the President. The Act allows U.S. corporations a one-time deduction of 85 percent of certain “cash dividends” received from controlled foreign corporations. The deduction is available to corporations during the tax year that includes October 22, 2004 or in the immediately subsequent tax year.  According to the Act, the amount of eligible dividends is limited to $500 million or the amount described as permanently reinvested earnings outside the U.S. in a company’s most recent audited financial statements filed with the SEC on or before June 30, 2003.  Based on these requirements, the Company has $934 million of cash held outside the U.S., which could be eligible for the special deduction in either fiscal year 2005 or 2006.  Due to the complexity of the repatriation provision, the Company is still evaluating the effects of the Act on our plan for repatriation of foreign earnings and the related impact to our tax provision.  It is anticipated that this

 

13

 

evaluation will be completed by the end of our current fiscal year.  The range of possible amounts that the Company is currently considering eligible for repatriation is between zero and $934 million.  The related potential range of income tax is between zero and $65 million.

 

Note 14 — Earnings Per Share

 

Basic earnings per share is computed based on the weighted average number of common shares outstanding.  Diluted earnings per share is computed based on the weighted average number of common shares outstanding adjusted by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued and reduced by the number of shares the Company could have repurchased from the proceeds of the potentially dilutive shares.  Potentially dilutive shares of common stock include stock options and other stock-based awards granted under stock-based compensation plans and shares committed to be purchased under the ESPP.  As a result of the adoption of EITF 04-8, the computation of diluted earnings per share for the three and nine months ended January 28, 2005 includes 727,358 shares related to the Old Debentures.  As required, diluted shares outstanding and diluted earnings per share for the three and nine months ended January 23, 2004 were also restated to include these shares.  However, the inclusion of the shares issuable upon conversion of the CoCos did not impact diluted earnings per share as previously reported.  T he potentially dilutive common shares related to the New Debentures would only be included in the diluted earnings per share calculation at such time in the future when the Company’s stock price rises above the conversion price.  The dilutive impact would be equal to the number of shares needed to satisfy the “in-the-money” value of the New Debentures, assuming conversion (see Notes 3 and 9).  Presented below is a reconciliation between basic and diluted weighted average shares outstanding (shares in millions):

 

		Three months ended				Nine months ended
		January 28, 2005		January 23, 2004		January 28, 2005		January 23, 2004
Basic		1,208.2		1,211.8		1,208.9		1,214.8
Effect of dilutive securities:
Employee stock options		8.8		8.8		9.2		9.8
Shares issuable upon conversion of CoCos		0.7		0.7		0.7		0.7
Other		1.4		1.8		1.2		1.9
Diluted		1,219.1		1,223.1		1,220.0		1,227.2

 

The calculation of weighted average diluted shares outstanding excludes options for approximately 12.4 million and 25.2 million common shares for the three and nine months ended January 28, 2005, and 16.7 million and 13.4 million common shares for the three and nine months ended January 23, 2004, respectively, as the exercise price of those options was greater than the average market price for the period, resulting in an anti-dilutive effect on diluted earnings per share.

 

Note 15 — Segment and Geographic Information

 

Segment information:

 

The Company maintains five operating segments, which are aggregated into one reportable segment — the manufacture and sale of device-based medical therapies. Each of the Company’s operating segments has similar economic characteristics, technology, manufacturing processes, customers, distribution and marketing strategies, regulatory environments, and shared infrastructures. Net sales by operating segment are as follows (in millions):

 

		Three months ended						Nine months ended
		January 28, 2005			January 23, 2004			January 28, 2005			January 23, 2004
Cardiac Rhythm Management		$	1,149.7		$	1,002.2		$	3,350.1		$	2,991.3
Spinal, ENT, and Navigation		535.6			433.9			1,525.7			1,230.7
Neurological and Diabetes		460.1			395.3			1,298.3			1,156.9
Vascular		221.5			211.7			618.7			599.7
Cardiac Surgery		163.8			150.7			483.8			443.2
		$	2,530.7		$	2,193.8		$	7,276.6		$	6,421.8

 

Geographic information :

 

Net sales to external customers by geography are as follows (in millions):

 

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		Three months ended						Nine months ended
		January 28, 2005			January 23, 2004			January 28, 2005			January 23, 2004
United States		$	1,678.8		$	1,485.4		$	4,890.9		$	4,390.3
Europe		532.3			449.3			1,488.1			1,271.8
Asia Pacific		253.4			206.6			715.1			606.1
Other Foreign		66.2			52.5			182.5			153.6
		$	2,530.7		$	2,193.8		$	7,276.6		$	6,421.8

 

Note 16 — Contingencies

 

The Company believes it has meritorious defenses against its claims and intends to vigorously contest them. Negative outcomes of the litigation matters discussed below generally are not considered probable or cannot be reasonably estimated. With the exception of the Depuy/AcroMed litigation (discussed below), the Company has not recorded reserves regarding these matters in the financial statements as of January 28, 2005.  The Company records a liability when a loss is known or considered probable and the amount can be reasonably estimated. If a loss is not probable or a probable loss cannot be reasonably estimated, a liability is not recorded. If the reasonable estimate of a known or probable loss is a range, and no amount within the range is a better estimate, the minimum amount of the range is accrued. While it is not possible to predict the outcome of the actions discussed below, the Company believes that costs associated with them could have a material adverse impact on the Company’s consolidated earnings, financial position or cash flows for any one interim or annual period.

 

On October 6, 1997, Cordis Corporation (Cordis), a subsidiary of Johnson & Johnson, Inc. (J&J), filed suit in federal court in the District Court of Delaware against Arterial Vascular Engineering, Inc., which Medtronic acquired in January 1999 and which is now known as Medtronic Vascular, Inc. (Medtronic Vascular). The suit alleged that Medtronic Vascular’s modular stents infringe certain patents now owned by Cordis. Boston Scientific Corporation is also a defendant in this suit. On December 22, 2000, a Delaware jury rendered a verdict that Medtronic Vascular’s previously marketed MicroStent and GFX® stents infringe valid claims of two Cordis patents and awarded damages to Cordis totaling approximately $270.0 million. On March 28, 2002, the District Court entered an order in favor of Medtronic Vascular, deciding as a matter of law that Medtronic Vascular’s MicroStent and GFX stents do not infringe the patents. Cordis appealed, and on August 12, 2003 the Court of Appeals for the Federal Circuit reversed the District Court’s decision and remanded the case to the District Court for further proceedings. The District Court has now issued a new claim construction and directed the parties to file new expert reports. On March 4, 2005 a new trial began and the liability phase of the trial is expected to be completed in mid-March. Neither the Court of Appeals nor the District Court has affirmed the jury’s verdict as to liability or damages. Consequently, Medtronic has not recorded an expense related to damages in this matter.

 

On December 24, 1997, Advanced Cardiovascular Systems, Inc. (ACS), a subsidiary of Guidant Corporation (Guidant), sued Medtronic Vascular in federal court in the Northern District of California alleging that Medtronic Vascular’s modular stents infringe certain patents held by ACS, and seeking injunctive relief and monetary damages. Medtronic Vascular denied infringement and in February 1998, Medtronic Vascular sued ACS in federal court in the District Court of Delaware alleging infringement of certain of its stent patents.  On January 5, 2005, the District Court found as a matter of law that ACS did not infringe any of Medtronic Vascular’s patents.  The Company intends to appeal the finding by the District Court.  On February 18, 2005 the jury found that the ACS patents are valid and that the Medtronic stents infringe those patents.  At a later date the District Court will hold an evidentiary hearing on Medtronic’s claim that the ACS patents are unenforceable due to inequitable conduct of ACS.  Issues of damages have been bifurcated and will not be addressed by a jury or the Court until some undetermined later date.

 

On September 12, 2000, Cordis filed an additional suit against Medtronic Vascular in the District Court of Delaware alleging that Medtronic Vascular’s S670, S660 and S540 stents infringe the patents asserted in the October 1997 Cordis case above. The Court temporarily stayed proceedings in this suit until the appeals were decided in the 1997 case discussed previously. The District Court has now lifted the stay and has scheduled a trial date for April 2006. This case is currently in the discovery stage. Medtronic has made a motion to stay the trial proceedings pending arbitration of Medtronic’s defense that its products are licensed under a 1997 Agreement between Medtronic and Cordis.  The Court has not set a date for a hearing on that motion.

 

On January 26, 2001, DePuy/AcroMed, a subsidiary of J&J, filed suit in U.S. District Court in Massachusetts alleging that MSD was infringing a patent relating to a design for a thoracolumbar multiaxial screw (MAS). In March 2002, DePuy/AcroMed supplemented its allegations to claim that MSD’s M10, M8 and Vertex® screws infringe the patent. On April 17, 2003 and February 26, 2004, the District Court ruled that the M10 and M8 multiaxial screws and the Vertex screws, respectively, do not infringe.  On October 1, 2004, a jury found that the MAS screw, which Medtronic no longer sells in the U.S. market, infringes under the doctrine of equivalents. The jury awarded damages against Medtronic of $21.0 million and on February 9, 2005, the court entered judgment, inclusive of prejudgment interest, in the amount of $24.3 million. The Company has recorded an expense equal to the $24.3 million judgment in the matter and is currently evaluating its appeal alternatives.

 

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On May 9, 2001, MSD filed a lawsuit against Dr. Gary Karlin Michelson and Karlin Technology, Inc. ( Defendants) in the U.S. District Court for the Western District of Tennessee. The complaint sought damages and injunctive relief against the Defendants for breach of purchase and license agreements relating to intellectual property in the field of threaded and non-threaded spinal interbody implants, fraud, breach of non-competition obligations and other claims. In October 2001, the Defendants filed several counterclaims against MSD, as well as a third-party complaint against Sofamor Danek Holdings, Inc., a related entity having a license for certain cervical plate technology, seeking damages and injunctive relief based on several claims, including breach of contract, infringement of several patents, fraud and unfair competition. The parties dispute the scope of the rights in the above agreements with respect to improvements conceived after the agreements were signed. In November 2003, the court issued a ruling limiting the Company’s rights under such purchase and license agreements to inventions disclosed in patents and patent applications identified in the agreements and excluding rights to later inventions. Trial commenced on June 1, 2004 on the parties’ claims of breach and Dr. Michelson’s and KTI’s claims of patent infringement and tortious interference with contractual relations.   On September 28, 2004, the jury delivered a verdict finding that:  (1) the license and purchase agreements remain in effect, but that; (2) MSD breached certain provisions of its various technology agreements with Dr. Michelson and KTI, for which damages of approximately $110.0 million were awarded; (3) certain MSD products infringe Dr. Michelson’s patents; (4) punitive damages were appropriate on certain breach of contract claims; and that (5) Medtronic had not breached any duties to Dr. Michelson or KTI. On October 12, 2004, the jury further awarded Dr. Michelson and KTI punitive damages totaling approximately $400.0 million against MSD on certain breach of contract claims.

 

The court is currently considering a number of equitable issues raised by the parties and has yet to enter judgment against MSD.  In its motions, MSD is asserting that notwithstanding the jury’s findings on infringement, MSD has an implied license to the affected technology on the basis of legal and equitable estoppel.  MSD further asserts that the Defendants are equitably prohibited from pursuing certain of their breach of contract claims on the grounds of waiver, estoppel, and acquiescence.  Additionally, MSD asserts that Dr. Michelson and KTI should be enjoined from competing with MSD as required by the agreements.  Dr. Michelson is seeking a declaratory judgment that he is entitled to terminate his license of certain cervical plate technology to Sofamor Danek Holdings, Inc.  MSD asserts Dr. Michelson is prohibited from seeking to terminate the license relating to cervical plate technology on the grounds of no material breach, waiver and/or ratification.  In addition, the Defendants are seeking: an expansion of the jury verdict to apply a royalty payable to KTI on all MSD sales of its INFUSE® product; additional damages for alleged unjust enrichment; a valuation of the damages for patent infringement found by the jury; enhanced damages from the court for willful infringement by MSD of one of Dr. Michelson’s patents; prejudgment interest; and other fees and costs, including attorney fees.  The parties agreed that Dr. Michelson would not seek to enjoin MSD’s rights to make, use or sell any of the products that the jury found to infringe patents issued after the dates of the license and purchase agreements without 10 days prior written notice.  On January 28, 2005, the court granted the parties’ joint request to stay any rulings or proceedings in the case while they attempt to settle remaining issues. The judge granted this request, and thereafter, MSD and Dr. Michelson jointly requested that the U.S. Court of Appeals for the Federal Circuit dismiss without prejudice a pending appeal by MSD. The dismissal was requested to consolidate all appeal issues into a single appeal, and does not prevent MSD from exercising any of its future appeal rights or from resuming the subject appeal at a later date. As of the date of this report, the court has not ruled on any of the parties’ motions and the parties are continuing their settlement discussions.  Medtronic and MSD strongly disagree with the damages awarded and believe that the award is unjustified and excessive. MSD intends to pursue all other appropriate post-trial remedies, including exercising its right to appeal and believes its position will ultimately be vindicated.  Given the uncertainty of these post-trial motions, the absence of judgment against it, and MSD’s intent to appeal the jury verdict as unjustified and excessive, Medtronic has not recorded an expense related to this matter.  Management cannot reasonably estimate the time frame in which this litigation will be resolved, including when and if any amounts will be paid.

 

On October 31, 2002, the Department of Justice filed a notice that the U.S. was declining to intervene in an action against Medtronic filed under seal in 1998 by two private attorneys (Relators), under the qui tam provisions of the federal False Claims Act. Relators alleged that Medtronic defrauded the FDA in obtaining pre-market approval to manufacture and sell Models 4004, 4004M, 4504 and 4504M pacemaker leads in the late 1980s and early 1990s. Relators further alleged that Medtronic did not provide information about testing of the pacemaker leads to the FDA in the years after the agency’s approval of the leads. Pursuant to the requirements of the False Claims Act, the case remained under seal while the U.S. Department of Justice determined whether to intervene in the action and directly pursue the claims on behalf of the U.S. On June 6, 2003, Medtronic’s motion to dismiss the action on several grounds was denied by the U.S. District Court, Southern District of Ohio. The Sixth Circuit Court of Appeals accepted an interlocutory appeal to review that decision, and heard oral argument on November 4, 2004. The Court of Appeals has taken the matter under advisement. A previously set trial date has been taken off the court’s calendar.

 

On May 2, 2003, Cross Medical Products, Inc. (Cross) sued MSD in the U.S. District Court for the Central District of California. The suit alleges that Medtronic’s CD HORIZON®, Vertex and Crosslink® products infringe certain patents owned by Cross. Medtronic has counterclaimed that Cross’ cervical plate products infringe certain patents of MSD, and Cross has filed a reply alleging that MSD infringes certain cervical plate patents of Cross. On May 19, 2004, the Court issued a ruling that held that the MAS, Vertex, M8, M10, CD HORIZON® SEXTANT™ and LEGACY™ screw products infringe one of the patents owned by Cross. A hearing on the validity of that patent was held on July 12, 2004, after which the Court ruled that the patents were valid.  Cross made a motion for permanent injunction on the multiaxial screw products, which the Court granted on September 20, 2004, but stayed the effect of the injunction until January 3, 2005.  MSD requested an expedited appeal of the ruling and the Federal Circuit Court of Appeals granted the request and will hear the appeal on March 11, 2005.  MSD has introduced new multiaxial screw products that are not subject to the injunction. 

 

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Cross moved for summary judgment of infringement regarding MSD’s new multiaxial screw products and that motion, and other summary judgment motions concerning Crosslink products, are pending.  In December 2004, the Court vacated all previously scheduled hearings and the trial date to allow it time to consider the pending motions and has not reset either a hearing date for the pending motions or the trial date.

 

On August 19, 2003, Edwards Lifesciences LLC and Endogad Research PTY Limited sued Medtronic Vascular, Cook Incorporated (Cook) and W.L. Gore & Associates, Inc. (Gore) in the U.S. District Court for the Northern District of California. The suit alleges that a patent owned by Endogad and licensed to Edwards is infringed by Medtronic Vascular’s AneuRx® Stent Graft and/or Talent™  Endoluminal Stent-Graft System, and by products of Cook and Gore. On June 4, 2004, Medtronic filed suit alleging that the inventor of the patent had breached a contract with Medtronic and is seeking to have Medtronic named as the rightful owner of the patent. The patent suit has been stayed pending the Court’s determination as to ownership of the patent in the suit brought by Medtronic against the inventor.

 

On September 4, 2003, Medtronic was informed by the Department of Justice that the government is investigating allegations that certain payments and other services provided to physicians by MSD constituted improper inducements under the federal Anti-Kickback Statute. The allegations were made as part of a civil qui tam complaint brought pursuant to the federal False Claims Act. On November 21, 2003, Medtronic was served with a government subpoena seeking documents in connection with these allegations. On September 2, 2004, Medtronic received a copy of a second civil qui tam complaint brought by a second relator asserting similar allegations under the False Claims Act. The Company views the second complaint as having arisen out of essentially similar facts and circumstances as the first qui tam complaint, and believes that the second complaint does not materially expand the nature of the existing inquiry in which the Company is cooperating. The cases remain under seal in the U.S. District Court for the Western District of Tennessee. The Company is cooperating fully with the investigations and is independently evaluating these matters, the internal processes associated therewith, and certain employment matters related thereto, in each case, under the supervision of a special committee of the Board.

 

On October 2, 2003, Etex Corporation served MSD, Medtronic and Medtronic International Ltd. with a Notice and Demand for Arbitration, under the terms of a Purchase and Option Agreement between Medtronic and Etex Corporation entered into on March 27, 2002. The arbitration demand alleges breach of the agreements, fraud, deceptive trade practices and antitrust violations and asks for specific performance and/or monetary damages.  Medtronic and its subsidiaries also filed a demand for damages alleging breach of the agreements. The binding arbitration is governed by Minnesota law and the federal Arbitration Act.  On March 3, 2005, the arbitrator heard final arguments and anticipates issuing a final decision some time in March 2005.

 

On October 2, 2003, Cordis sued Medtronic Vascular in the U.S. District Court, Northern District of California, alleging that the S7 stent delivery system infringes certain catheter patents owned by Cordis. Pursuant to stipulation of the parties, the Court has stayed the suit and referred the matter to arbitration.  The arbitrators have not yet been selected.

 

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