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| EW > SEC Filings for EW > Form 10-Q on 7-Nov-2008 | All Recent SEC Filings |
7-Nov-2008
Quarterly Report
This report contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. The Company intends the forward-looking statements
contained in this report to be covered by the safe harbor provisions of such
Acts. All statements other than statements of historical fact in this report or
referred to or incorporated by reference into this report are "forward-looking
statements" for purposes of these sections. These statements include, among
other things, any predictions of earnings, revenues, expenses or other financial
items, any statements of plans, strategies and objectives of management for
future operations, any statements concerning the Company's future operations,
financial conditions and prospects, any statements regarding the timing of
regulatory approvals or new product introductions, and any statement of
assumptions underlying any of the foregoing. These statements can sometimes be
identified by the use of the forward-looking words such as "may," "believe,"
"will," "expect," "project," "estimate," "should," "anticipate," "plan,"
"continue," "seek," "pro forma," "forecast," or "intend" or other similar words
or expressions or the negative thereof. Investors are cautioned not to unduly
rely on such forward-looking statements. These forward-looking statements are
subject to substantial risks and uncertainties that could cause the Company's
future business, financial condition, results of operations, or performance to
differ materially from the Company's historical results or those expressed in
any forward-looking statements contained in this report. Investors should
carefully review the information contained in, or incorporated by reference
into, the Company's annual report on Form 10-K for the year ended December 31,
2007 for a description of certain of these risks and uncertainties.
Overview
Edwards Lifesciences Corporation ("Edwards Lifesciences" or the "Company") is a global provider of technologies that are designed to treat advanced cardiovascular disease. Edwards Lifesciences focuses on providing products and technologies to address specific cardiovascular conditions including heart valve disease, critical care technologies and peripheral vascular disease.
The products and technologies provided by Edwards Lifesciences to treat advanced cardiovascular disease are categorized into five main areas: Heart Valve Therapy, Critical Care, Cardiac Surgery Systems, Vascular and Other Distributed Products.
Edwards Lifesciences' Heart Valve Therapy portfolio is comprised of tissue heart valves and heart valve repair products. A pioneer in the development and commercialization of heart valve products, Edwards Lifesciences is the world's leading manufacturer of tissue heart valves and repair products used to replace or repair a patient's diseased or defective heart valve. In the Critical Care area, Edwards Lifesciences is a world leader in hemodynamic monitoring equipment used to measure a patient's cardiovascular function and in disposable pressure transducers, and also provides central venous access products for fluid and drug delivery. The Company's Cardiac Surgery Systems portfolio comprises a diverse line of products for use during cardiac surgery including cannula, EMBOL-X technologies, and other disposable products used during cardiopulmonary bypass procedures. Cardiac Surgery Systems also included transmyocardial revascularization ("TMR") products until March 2007 when the Company sold the distribution rights to its TMR products. In December 2007, the Company acquired the CardioVations line of products used in minimally invasive heart valve surgery. Edwards Lifesciences' Vascular portfolio includes a line of balloon catheter-based products, surgical clips and inserts, artificial implantable grafts, and stents ("LifeStent" products) for which approval is being sought for use in the treatment of peripheral vascular disease. The Company sold the LifeStent product line in January 2008, but will continue to manufacture these products for the buyer until the earlier of mid-2010 or the transfer of manufacturing to the buyer. Lastly, Other Distributed Products consisted primarily of intra-aortic balloon pumps. This business was terminated at the end of 2007.
Recently Adopted Accounting Standards
In September 2006, the Financial Accounting Standards Board ("FASB") issued Statement of Financial Accounting Standards ("SFAS") No. 157, "Fair Value Measurements" ("SFAS 157"), which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. SFAS 157 is effective for financial statements issued for fiscal years beginning after November 15, 2007, and interim periods within those fiscal years. In February 2008, the FASB issued FASB Staff Position 157-2, "Effective Date of FASB Statement No. 157" ("FSP 157-2"), which delays the effective date of SFAS No. 157 for all non-financial assets and non-financial liabilities, except for those items that are recognized or disclosed at fair value in the financial statements on a recurring basis, until fiscal years beginning after November 15, 2008. In October 2008, the FASB issued FASB Staff Position 157-3, "Determining the Fair Value of a Financial Asset When the Market for That Asset is Not Active" ("FSP 157-3"). FSP 157-3 clarifies the application of SFAS 157 in a market that is not active and provides an example to illustrate key considerations in determining the fair value of a financial asset when the market for that financial asset is not active. FSP 157-3 was effective upon issuance, including prior periods for which financial statements have not yet been issued. The Company's adoption of SFAS No. 157, except as it applies to those non-financial assets and liabilities affected by the one-year delay, did not have a material impact on the Company's consolidated financial statements. The Company does not expect the adoption of SFAS 157 related to its non-financial assets and liabilities to have a material impact on its consolidated financial statements. The adoption of FSP 157-3 did not have an impact on the Company's consolidated financial statements.
In September 2006, the FASB issued SFAS No. 158, "Employers' Accounting for Defined Benefit Pension and Other Postretirement Plans-An Amendment of FASB Statements No. 87, 88, 106, and 132(R)" ("SFAS 158"). SFAS 158 requires employers to recognize the overfunded or underfunded status of a single-employer defined benefit postretirement plan as an asset or liability on its balance sheet and to recognize changes in that funded status in comprehensive income. In addition, SFAS 158 requires employers to measure the funded status of a plan as of the date of its year-end balance sheet. SFAS 158 provides different effective dates for the recognition and related disclosure provisions, and for the required change to a fiscal year-end measurement date. In December 2006, the Company applied the requirements to recognize the funded status of its benefit plans and made the required disclosures. The requirement to measure plan assets and benefit obligations as of the date of the employer's fiscal year-end balance sheet is effective for the Company for the fiscal year ending December 31, 2008. SFAS 158 provides two approaches for transitioning to a fiscal year-end measurement date. The Company will adopt the measurement date provisions using the "one measurement" approach. Under this approach, the Company will use the measurement determined as of October 31, 2007 and will recognize the net benefit expense for the transition period from November 1, 2007 through December 31, 2007 in retained earnings at December 31, 2008. The adoption of the measurement date provisions of SFAS 158 will not have a material impact on the Company's consolidated financial statements.
In June 2007, the FASB ratified the consensus reached by the Emerging Issues Task Force ("EITF") in EITF Issue No. 07-3, "Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities" ("EITF 07-3"). EITF 07-3 requires that nonrefundable advance payments for goods and services that will be used in future research and development activities be deferred and capitalized until the related service is performed or the goods are delivered. EITF 07-3 is effective for fiscal years beginning after December 15, 2007. The adoption of this standard did not have a material impact on the Company's consolidated financial statements.
New Accounting Standards Not Yet Adopted
In December 2007, the FASB issued SFAS No. 141 (revised 2007), "Business Combinations" ("SFAS 141R"). SFAS 141R establishes principles and requirements for how the acquirer of a business recognizes and measures in its financial statements the identifiable assets acquired, the liabilities assumed, and any noncontrolling interest in the acquiree. SFAS 141R also provides guidance for recognizing and measuring goodwill acquired in the business combination and determines what information to disclose to enable users of the financial statements to evaluate the nature and financial effects of the business combination. Among other requirements, SFAS 141R expands the definition of a business combination, requires acquisitions to be accounted for at fair value, and requires transaction costs and restructuring charges to be expensed. SFAS 141R is effective for fiscal years beginning on or after December 15, 2008. SFAS 141R will impact the Company if it is involved in a business combination.
In March 2008, the FASB issued SFAS No. 161, "Disclosures about Derivative Instruments and Hedging Activities-an amendment of FASB Statement No. 133" ("SFAS 161"). SFAS 161 requires enhanced disclosures about an entity's derivative instruments and hedging activities, including (a) how and why an entity uses derivative instruments, (b) how derivative instruments and related hedged items are accounted for and (c) how derivative instruments and related hedged items affect an entity's financial position, financial performance and cash flows. SFAS 161 is effective for fiscal years and interim periods beginning after November 15, 2008. The Company does not expect the adoption of SFAS 161 to have a material impact on its consolidated financial statements.
In April 2008, the FASB issued FASB Staff Position No. 142-3, "Determination of the Useful Life of Intangible Assets" ("FSP 142-3"). FSP 142-3 amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under SFAS No. 142, "Goodwill and Other Intangible Assets." FSP 142-3 applies to intangible assets that are acquired individually or with a group of other assets acquired in business combinations and asset acquisitions. FSP 142-3 also requires expanded disclosure related to the determination of intangible asset useful lives. FSP 142-3 is effective for fiscal years beginning after December 15, 2008. The Company is currently evaluating the potential impact of FSP 142-3 on its consolidated financial statements.
In September 2008, the FASB issued FSP 133-1 and FIN 45-4, "Disclosures about Credit Derivatives and Certain Guarantees: An Amendment of FASB Statement No. 133 and FASB Interpretation No. 45; and Clarification of the Effective Date of FASB Statement No. 161" ("FSP 133-1 and FIN 45-4"). FSP 133-1 and FIN 45-4 amends and enhances disclosure requirements for sellers of credit derivatives and financial guarantees. It also clarifies that the disclosure requirements of SFAS No. 161 are effective for quarterly periods beginning after November 15, 2008, and fiscal years that include those periods. FSP 133-1 and FIN 45-4 is effective for reporting periods (annual or interim) ending after November 15, 2008. The Company does not expect the adoption of this standard to have a material impact on its consolidated financial statements.
Results of Operations
Net Sales Trends
The following is a summary of United States and international net sales
(dollars in millions):
Three Months Ended Nine Months Ended
September 30, Percent September 30, Percent
2008 2007 Change Change 2008 2007 Change Change
United States $ 135.6 $ 118.1 $ 17.5 14.8 % $ 410.8 $ 362.7 $ 48.1 13.3 %
International 168.0 143.3 24.7 17.2 % 517.2 435.4 81.8 18.8 %
Total net sales $ 303.6 $ 261.4 $ 42.2 16.1 % $ 928.0 $ 798.1 $ 129.9 16.3 %
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In the United States, the $17.5 million and $48.1 million increases in net sales for the three and nine months ended September 30, 2008, respectively, were due primarily to:
º •
º CardioVations products, which increased net sales by $5.9 million and
$17.7 million, respectively. The Company purchased the CardioVations
product line in December 2007;
º •
º LifeStent products, which increased net sales by $4.6 million and
$13.7 million, respectively. LifeStent sales include end-customer
sales recorded prior to the divestiture of LifeStent in mid-January
2008, and sales after the divestiture resulting from the on-going
manufacturing requirements of the sale agreement (all of which are
recorded in the United States), which will continue until the earlier
of mid-2010 or the transfer of manufacturing to the buyer;
º •
º Critical Care products, which increased net sales by $3.6 million and
$11.1 million, respectively, driven primarily by the FloTrac minimally
invasive monitoring system, hemofiltration products, and pressure
monitoring products; and
º •
º Heart Valve Therapy products, which increased net sales by
$3.3 million and $7.2 million, respectively, driven primarily by the
Carpentier-Edwards PERIMOUNT Magna with ThermaFix valve.
International net sales increased $24.7 million and $81.8 million for the three and nine months ended September 30, 2008, respectively, due primarily to:
º •
º Heart Valve Therapy products, which increased net sales by
$22.2 million and $66.8 million, respectively, driven primarily by the
Edwards SAPIEN transcatheter heart valve, the Carpentier-
º •
º Critical Care products, which increased net sales by $10.2 million and
$37.7 million, respectively, driven primarily by the FloTrac minimally
invasive monitoring system, pressure monitoring products, and
hemofiltration products;
partially offset by
º •
º decreases of $9.4 million and $27.6 million, respectively, related to
the discontinuation of distributed sales in Japan of intra-aortic
balloon pumps and the divestiture of the LifeStent product line.
The benefit of foreign currency exchange rate fluctuations included above increased net sales by $11.2 million and $43.7 million for the three and nine months ended September 30, 2008, respectively, due primarily to the strengthening of the Euro and Japanese yen against the United States dollar. The impact of foreign currency exchange rate fluctuations on net sales is not indicative of the impact on net income due to the corresponding effect of foreign currency exchange rate fluctuations on international manufacturing and operating costs and the Company's hedging activities. For more information see Item 3, "Quantitative and Qualitative Disclosures About Market Risk."
Net Sales by Product Line
The following table is a summary of net sales by product line (dollars in
millions):
Three Months Ended Nine Months Ended
September 30, Percent September 30, Percent
2008 2007 Change Change 2008 2007 Change Change
Heart Valve Therapy $ 148.4 $ 122.8 $ 25.6 20.8 % $ 457.7 $ 383.6 $ 74.1 19.3 %
Critical Care 110.3 96.5 13.8 14.3 % 333.6 284.8 48.8 17.1 %
Cardiac Surgery 21.4 13.8 7.6 55.1 % 66.3 45.8 20.5 44.8 %
Systems
Vascular 23.5 22.4 1.1 4.9 % 70.4 64.9 5.5 8.5 %
Other Distributed - 5.9 (5.9 ) (100.0 )% - 19.0 (19.0 ) (100.0 )%
Products
Total net sales $ 303.6 $ 261.4 $ 42.2 16.1 % $ 928.0 $ 798.1 $ 129.9 16.3 %
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The $25.6 million and $74.1 million increases in net sales of Heart Valve Therapy products for the three and nine months ended September 30, 2008, respectively, were due primarily to:
º •
º the launch of the Edwards SAPIEN transcatheter heart valve in Europe
during the fourth quarter of 2007, which increased net sales by
$12.8 million and $34.2 million, respectively; and
º •
º pericardial tissue valves, which increased net sales by $11.9 million
and $36.6 million, respectively, primarily as a result of the
Carpentier-Edwards PERIMOUNT Magna Ease valve, the Magna with
ThermaFix aortic valve, and the launch of the Magna aortic valve in
Japan.
The Company expects that its SAPIEN transcatheter heart valve and its PERIMOUNT Magna Ease and Magna with ThermaFix valves will continue to be strong contributors to 2008 sales. The Company launched the Magna Ease valve in Europe in May 2007, and is expecting to introduce this product into the United States in 2009, pending regulatory approval. The Company's PERIMOUNT Magna mitral valve is gaining physician acceptance in Europe, and the Company received Food and Drug Administration ("FDA") approval during the third quarter of 2008 and launched this product into the United States during September 2008. In Japan, the Company received regulatory and reimbursement
approval for its Magna aortic valve in the second quarter of 2008, and introduced this product in Japan during June 2008. The Company expects this product to continue to accelerate its growth rate in Japan. The Company had its first implants of the Carpentier-Edwards Physio II ring during the third quarter of 2008 and concluded that some modifications to the ring accessories are necessary. Therefore, the Company now expects to launch the product in the United States and Europe during the first quarter of 2009. Physio II is the next generation repair product for the degenerative segment of mitral repair.
The $13.8 million and $48.8 million increases in net sales of Critical Care products for the three and nine months ended September 30, 2008, respectively, were due primarily to:
º •
º FloTrac systems, which increased net sales by $6.1 million and
$15.5 million, respectively;
º •
º core Critical Care products, which increased net sales by $5.4 million
and $25.0 million, respectively, driven primarily by market share
gains in pressure monitoring products and PreSep, the Company's
central venous oximetry catheter for early detection of sepsis; and
º •
º hemofiltration products, which increased net sales by $2.3 million and
$8.3 million, respectively.
The Company expects worldwide FloTrac system sales to continue to be a significant contributor to Critical Care sales growth in 2008. During the second quarter of 2008, the Company introduced an enhancement to the FloTrac system that provides additional information in the operating room, and the Company plans to continue introducing additional product enhancements that will enable FloTrac to address a wider range of patients.
The $7.6 million and $20.5 million increases in net sales of Cardiac Surgery Systems products for the three and nine months ended September 30, 2008, respectively, were due primarily to the acquisition of the CardioVations product line in December 2007, which increased net sales by $7.4 million and $22.2 million, respectively. These increases were partially offset by the discontinuation of the Brazil-based perfusion product line, which resulted in net sales decreases of $0.8 million and $4.0 million, respectively, for the three and nine months ended September 30, 2008.
The $1.1 million and $5.5 million increases in net sales of Vascular products for the three and nine months ended September 30, 2008, respectively, were due primarily to increased sales of LifeStent products. In January 2008, the Company completed the sale of the LifeStent product line. The Company has agreed to provide transition services, including manufacturing, to the buyer until the earlier of mid-2010 or the transfer of manufacturing to the buyer, and will continue to pursue pre-market approval for a superficial femoral artery indication. LifeStent sales include end-customer sales recorded prior to the divestiture of LifeStent in mid-January and sales after the divestiture resulting from the on-going manufacturing requirements of the sale agreement.
Other Distributed Products
The $5.9 million and $19.0 million decreases in net sales of Other
Distributed Products for the three and nine months ended September 30, 2008,
respectively, were due to the termination at the end of 2007 of distributed
sales in Japan of intra-aortic balloon pumps.
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Gross Profit
Three Months Ended Nine Months Ended
September 30, September 30,
2008 2007 Change 2008 2007 Change
Gross profit as a percentage of 65.4 % 65.3 % 0.1 pts. 65.4 % 65.1 % 0.3 pts.
net sales
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The 0.1 and 0.3 percentage point increases in gross profit as a percentage of net sales for the three and nine months ended September 30, 2008, respectively, were driven by:
º •
º a 2.0 percentage point increase in the international gross profit as a
percentage of net sales for both the three and nine months ended
September 30, 2008, due to a more profitable product mix, primarily
higher sales of Heart Valve Therapy products and FloTrac systems,
combined with the discontinuation of lower margin perfusion products
and intra-aortic balloon pumps;
partially offset by
º •
º a 0.2 percentage point and a 0.6 percentage point decrease in the
United States gross profit as a percentage of net sales for the three
and nine months ended September 30, 2008, respectively, due primarily
to sales of LifeStent products under the on-going manufacturing
requirements of the LifeStent sale agreement, partially offset by a
more profitable product mix, primarily higher sales of FloTrac
systems; and
º •
º the impact from the expiration of foreign currency hedging contracts.
Selling, General and Administrative (SG&A) Expenses
Three Months Ended Nine Months Ended
September 30, September 30,
2008 2007 Change 2008 2007 Change
(dollars in millions)
SG&A expenses $ 119.3 $ 103.2 $16.1 $ 360.4 $ 303.5 $56.9
SG&A expenses as a
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The $16.1 million and $56.9 million increases in selling, general and
administrative expenses for the three and nine months ended September 30, 2008,
respectively, and the 0.8 percentage point increase in selling, general and
administrative expenses as a percentage of net sales for the nine months ended
September 30, 2008, were due primarily to (1) the impact of foreign currency
(primarily the strengthening of the Euro against the United States dollar),
(2) higher sales related spending, including investments for the Edwards SAPIEN
transcatheter heart valve launch in Europe, and (3) higher compensation expense
related to the Company's strong sales performance.
Research and Development Expenses
Three Months Ended Nine Months Ended
September 30, September 30,
2008 2007 Change 2008 2007 Change
. . .
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