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| EW > SEC Filings for EW > Form 10-Q on 8-May-2009 | All Recent SEC Filings |
8-May-2009
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, plans or expectations with respect to development activities, clinical
trials, or regulatory approvals, any statements of plans, strategies, and
objectives of management for future operations, any statements concerning the
Company's future operations, financial conditions and prospects, 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," "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, 2008 for a description of certain of these risks and uncertainties.
Overview
Edwards Lifesciences Corporation ("Edwards Lifesciences" or the "Company") is a global leader in products and technologies designed to treat advanced cardiovascular disease. The Company is focused specifically on technologies that treat structural heart disease and critically ill patients.
The products and technologies provided by Edwards Lifesciences to treat advanced cardiovascular disease are categorized into four main areas: Heart Valve Therapy; Critical Care; Cardiac Surgery Systems; and Vascular.
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 includes the Company's minimally invasive surgery ("MIS") product line. 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.
The healthcare marketplace continues to be competitive with strong global and local competitors. The Company competes with many companies, ranging from small start-up enterprises to companies that are larger and more established than Edwards Lifesciences with access to significant financial resources. Furthermore, rapid product development and technological change characterize the market in which the Company competes. Global demand for healthcare is increasing as the population ages.
There is mounting pressure to contain healthcare costs in the face of this increasing demand, which has resulted in pricing and market share pressures. The cardiovascular segment of the medical device industry is dynamic, and technology, cost-of-care considerations, regulatory reform, industry and customer consolidation, and evolving patient needs are expected to continue to drive change.
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 defined fair value, established a framework for measuring fair value, and expanded disclosures about fair value measurements. In February 2008, the FASB issued FASB Staff Position ("FSP") No. 157-2, "Effective Date of FASB Statement No. 157" ("FSP 157-2"), which delayed the effective date of SFAS 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. The Company's adoption of SFAS 157, 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.
In December 2007, the FASB ratified the consensus reached by the Emerging Issues Task Force ("EITF") in EITF Issue No. 07-1, "Accounting for Collaborative Arrangements" ("EITF 07-1"). EITF 07-1 defines collaborative arrangements and establishes reporting requirements for transactions between participants in a collaborative arrangement and between participants in the arrangement and third parties. EITF 07-1 also establishes the appropriate income statement presentation and classification for joint operating activities and payments between participants, as well as the sufficiency of the disclosures related to these arrangements. EITF 07-1 was effective for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. Retrospective application to all prior periods presented is required for all collaborative arrangements existing as of the effective date. The Company's adoption of EITF 07-1 did not have a material impact on its consolidated financial statements.
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 was 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 was effective for fiscal years and interim periods beginning after November 15, 2008. The adoption of this standard did not have a material impact on the Company's consolidated financial statements.
In April 2008, the FASB issued FSP No. FAS 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 was effective for fiscal years beginning after December 15, 2008. The adoption of this standard did not have a material impact on the Company's consolidated financial statements.
In November 2008, the FASB ratified the consensus reached by the EITF in EITF Issue No. 08-6, "Equity Method Investment Accounting Considerations" ("EITF 08-6"). EITF 08-6 clarifies the accounting for certain transactions and impairment considerations involving equity method investments. EITF 08-6 was effective for fiscal years beginning after December 15, 2008, with early adoption prohibited. The adoption of this standard did not have a material impact on the Company's consolidated financial statements.
In November 2008, the FASB ratified the consensus reached by the EITF in EITF Issue No. 08-7, "Accounting for Defensive Intangible Assets" ("EITF 08-7"). EITF 08-7 clarifies the accounting for certain separately identifiable intangible assets which an acquirer does not intend to actively use but intends to hold to prevent its competitors from obtaining access to them. EITF 08-7 requires an acquirer in a business combination to account for a defensive intangible asset as a separate unit of accounting which should be amortized to expense over a period the asset diminishes in value. EITF 08-7 was effective for fiscal years beginning after December 15, 2008, with early adoption prohibited. The adoption of this standard did not have a material impact on the Company's consolidated financial statements.
In April 2009, the FASB issued FSP No. FAS 141 (R)-1, "Accounting for Assets Acquired and Liabilities Assumed in a Business Combination That Arise from Contingencies" (FSP 141R-1"). FSP 141R-1 amends the guidance in SFAS 141R to require that assets acquired and liabilities assumed in a business combination that arise from contingencies be recognized at fair value if fair value can be reasonably determined. If the fair value cannot be reasonably determined, then the assets and liabilities should be recognized at the amount that would be recognized in accordance with SFAS No. 5, "Accounting for Contingencies," and FASB Interpretation No. 14, "Reasonable Estimation of the Amount of a Loss." 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 2008, the FASB issued FSP No. FAS 132(R)-1, "Employers' Disclosures about Postretirement Benefit Plan Assets" ("FSP 132R-1"). FSP 132R-1 requires additional disclosures about (a) how investment allocation decisions are made by management, (b) major categories of plan assets, (c) inputs and valuation techniques used to develop fair value measurements, including disclosures similar to that required under SFAS 157, and (d) significant concentrations of risk. FSP 132R-1 is effective for fiscal years ending after December 15, 2009. The Company does not expect the adoption of FSP 132R-1 will have a material impact on its consolidated financial statements.
In April 2009, the FASB issued FSP No. FAS 157-4, "Determining Fair Value When the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not Orderly" ("FSP 157-4"). FSP 157-4 provides additional guidance for estimating fair value in accordance with SFAS 157 when the volume and level of activity for the asset or liability have significantly decreased. FSP 157-4 also includes guidance on identifying circumstances that indicate a transaction is not orderly. FSP 157-4 is effective for interim and annual reporting periods ending after June 15, 2009. The Company does not expect the adoption of FSP 157-4 will have a material impact on its consolidated financial statements.
In April 2009, the FASB issued FSP No. FAS 115-2 and FAS 124-2, "Recognition and Presentation of Other-Than-Temporary Impairments" ("FSP 115-2 and 124-2"). FSP 115-2 and 124-2 amends the other-than-temporary impairment guidance related to debt securities and expands and increases the frequency of existing disclosures about other-than-temporary impairments for debt and equity securities. In addition, FSP 115-2 and 124-2 requires that the annual disclosures in SFAS No. 115, "Accounting for Certain Investments in Debt and Equity Securities," and FSP No. FAS 115-1 and FAS 124-1, "The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments," be made for interim periods. FSP 115-2 and 124-2 is effective for interim and annual reporting periods ending after June 15, 2009. The Company does not expect the adoption of FSP 115-2 and 124-2 will have a material impact on its consolidated financial statements.
In April 2009, the SEC issued Staff Accounting Bulletin ("SAB") No. 111, "Other Than Temporary Impairment of Certain Investments in Debt and Equity Securities" ("SAB 111"). SAB 111 amends SAB Topic 5M to reflect the guidance in FSP 115-2 and 124-2. SAB 111 maintains the prior staff views related to equity securities but amends SAB Topic 5M to exclude debt securities from its scope. The Company does not expect the adoption of SAB 111 will have a material impact on the Company's consolidated financial statements.
In April 2009, the FASB issued FSP No. FAS 107-1 and APB 28-1, "Interim Disclosures about Fair Value of Financial Instruments" ("FSP 107-1 and 28-1"). FSP 107-1 and 28-1 requires disclosures about the fair value of financial instruments for interim reporting periods of publicly traded companies as well as in annual financial statements. FSP 107-1 and 28-1 is effective for interim reporting periods ending after June 15, 2009. The Company does not expect the adoption of FSP 107-1 and 28-1 will 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
March 31, Percent
2009 2008 Change Change
United States $ 134.9 $ 135.5 $ (0.6 ) (0.4 )%
International 178.6 161.3 17.3 10.7 %
Total net sales $ 313.5 $ 296.8 $ 16.7 5.6 %
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In the United States, the $0.6 million decrease in net sales for the three months ended March 31, 2009 was due primarily to:
º •
º Vascular products, which decreased net sales by $4.1 million,
primarily due to the divestiture of the LifeStent product line in
mid-January 2008. Sales after the divestiture result from the on-going
manufacturing requirements of the sale agreement, which will continue
until the earlier of mid-2010 or the transfer of manufacturing to the
buyer;
partially offset by:
º •
º Heart Valve Therapy products, which increased net sales by
$3.2 million, driven primarily by the Magna mitral valve and the
Carpentier-Edwards PERIMOUNT Magna with ThermaFix valve.
International net sales increased $17.3 million for the three months ended March 31, 2009 due primarily to:
º •
º Heart Valve Therapy products, which increased net sales by
$20.5 million, driven primarily by the Edwards SAPIEN transcatheter
heart valve, the Carpentier-Edwards PERIMOUNT Magna Ease valve, and
the launch of the Magna aortic valve in Japan in the second quarter of
2008;
partially offset by:
º •
º Vascular products, which decreased net sales by $1.7 million,
primarily due to the divestiture of the LifeStent product line.
Foreign currency exchange rate fluctuations included above decreased net sales by $10.0 million for the three months ended March 31, 2009 due primarily to the weakening of the Euro against the United States dollar. The impact of foreign currency exchange rate fluctuations on net sales would not necessarily be 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
March 31, Percent
2009 2008 Change Change
Heart Valve Therapy $ 170.4 $ 146.7 $ 23.7 16.2 %
Critical Care 104.5 106.7 (2.2 ) (2.1 )%
Cardiac Surgery Systems 22.5 21.4 1.1 5.1 %
Vascular 16.1 22.0 (5.9 ) (26.8 )%
Total net sales $ 313.5 $ 296.8 $ 16.7 5.6 %
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The $23.7 million increase in net sales of Heart Valve Therapy products for the three months ended March 31, 2009 was due primarily to:
º •
º the Edwards SAPIEN transcatheter heart valve, which increased net
sales by $16.5 million; and
º •
º pericardial tissue valves, which increased net sales by $8.7 million,
primarily as a result of the Carpentier-Edwards PERIMOUNT Magna Ease
valve, the Magna with ThermaFix aortic and mitral valves, and the
launch of the Magna aortic valve in Japan in the second quarter of
2008.
The Company expects that its SAPIEN transcatheter heart valve will continue to be a strong contributor to 2009 sales, and anticipates introducing new products across the aortic, mitral, and valve repair categories. The Company expects to introduce the Magna Ease valve into the United States in the third quarter of 2009, pending regulatory approval. The Company expects to launch an enhancement to its Magna Mitral valve, called the Magna Mitral Ease, in the second half of 2009 in the United States and Europe. The Magna Mitral Ease will extend the Magna platform by providing improved MIS capabilities and ease of implantation. The Company launched the Carpentier-Edwards Physio II ring in the United States and Europe during the first quarter of 2009, and expects this product to lift its growth in the repair segment. Physio II is the next generation repair product for the degenerative segment of mitral repair. In Japan, the Company received regulatory approval for its IMR
ETlogix ring during the first quarter of 2009, and expects to launch this product in Japan during the second quarter of 2009.
The $2.2 million decrease in net sales of Critical Care products for the three months ended March 31, 2009 was due primarily to:
º •
º core Critical Care products, which decreased net sales by
$3.6 million, due primarily to decreased sales of advanced hemodynamic
monitoring equipment; and
º •
º hemofiltration products, which decreased net sales by $1.8 million;
partially offset by:
º •
º FloTrac systems, which increased net sales by $3.2 million.
The Company expects worldwide FloTrac system sales to continue to be a significant contributor to Critical Care sales growth in 2009, and that it will continue to expand the market for minimally invasive hemodynamic monitoring. During the first quarter of 2009, the Company launched a third generation algorithm enhancement for the FloTrac system that enhances its accuracy when used in patients with sepsis and other critical illnesses. At the end of 2008, the Company purchased intellectual property that is expected to be incorporated into a substantial upgrade for the FloTrac system, which is planned for launch in the third quarter of 2009. In addition, the Company anticipates launching a new hardware platform in the third quarter of 2009 with a simpler, more intuitive informational display, and expects to ultimately consolidate all parameters into one platform.
During the fourth quarter of 2008, the Company entered into a collaboration agreement with DexCom, Inc. to develop products for continuously monitoring blood glucose levels in patients hospitalized for a variety of conditions. During 2009, the Company expects to complete clinical studies to support regulatory approval and, if the clinical studies are successful, anticipates introducing a first generation product in Europe by year end.
The $1.1 million increase in net sales of Cardiac Surgery Systems products for the three months ended March 31, 2009 was due primarily to MIS products, which increased net sales by $1.2 million. In June 2009, the Company expects to launch its EndoDirect arterial cannula system, which provides cardiac surgeons with an additional minimally invasive alternative when femoral access is not an option.
Vascular
The $5.9 million decrease in net sales of Vascular products for the three
months ended March 31, 2009 was due primarily to the divestiture of the
LifeStent product line in mid-January 2008. The Company agreed to provide
transition services, including manufacturing, to the buyer until the earlier of
mid-2010 or the transfer of manufacturing to the buyer. LifeStent sales after
the divestiture result from the on-going manufacturing requirements of the sale
agreement.
Gross Profit
Three Months Ended
March 31,
2009 2008 Change
Gross profit as a percentage of net sales 69.1 % 65.3 % 3.8 pts.
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The 3.8 percentage point increase in gross profit as a percentage of net sales for the three months ended March 31, 2009 was driven by:
º •
º a 1.8 percentage point increase in international gross profit as a
percentage of net sales due to a more profitable product mix,
primarily higher sales of Heart Valve Therapy products and FloTrac
systems;
º •
º a 1.5 percentage point increase in the United States gross profit as a
percentage of net sales due primarily to a more profitable product
mix, primarily from reduced sales of LifeStent products under the
on-going manufacturing requirements of the LifeStent sale agreement;
and
º •
º the impact from the expiration of foreign currency hedging contracts;
partially offset by:
º •
º the unfavorable impact of Critical Care manufacturing variations.
Selling, General and Administrative (SG&A) Expenses
Three Months Ended
March 31,
2009 2008 Change
(dollars in millions)
SG&A expenses $ 121.9 $ 114.6 $7.3
SG&A expenses as a percentage of net sales 38.9 % 38.6 % 0.3 pts.
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The $7.3 million increase in SG&A expenses and the 0.3 percentage point increase in SG&A expenses as a percentage of net sales for the three months ended March 31, 2009 was due primarily to (1) investments for the transcatheter heart valve program in Europe and (2) higher sales-related spending in the Heart Valve Therapy and Critical Care product lines. The increases were partially offset by the favorable impact of foreign currency (primarily the weakening of the Euro against the United States dollar) in the amount of $3.9 million.
Research and Development Expenses
Three Months Ended
March 31,
2009 2008 Change
(dollars in millions)
Research and development expenses $ 39.9 $ 32.9 $7.0
Research and development expenses as a 12.7 % 11.1 % 1.6 pts.
percentage of net sales
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The increase in research and development expenses for the three months ended March 31, 2009 was due primarily to additional investments in the transcatheter heart valve and glucose programs.
The following are the developments related to the Company's transcatheter aortic valve replacement program (formerly Percutaneous Valve Technologies, Inc.'s percutaneous aortic valve program):
º •
º the Company received conditional Investigational Device Exemption
("IDE") approval from the U.S. Food and Drug Administration ("FDA") in
March 2007 to initiate its PARTNER trial, a pivotal clinical trial of
the Company's Edwards SAPIEN transcatheter heart valve technology. The
PARTNER trial, which has two study arms, began enrollment during the
second quarter of 2007 and will evaluate the Edwards SAPIEN
transcatheter heart valve in patients who are considered at high risk
for conventional open-heart valve surgery. In the first study arm
("Cohort A"), patients are randomized on a 1:1 basis to either high
risk surgery or the Edwards
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