- EW Dashboard
- Financials
- Filings
-
Holdings
- Transcripts
- ETFs
- Insider
- Institutional
- Shorts
-
CORRESP Filing
Edwards Lifesciences (EW) CORRESPCorrespondence with SEC
Filed: 8 Feb 08, 12:00am
Edwards Lifesciences Corporation
One Edwards Way
Irvine, California 92614
Telephone: 949.250.2500
February 8, 2008
Mr. Brian Cascio
Branch Chief
Mail Stop 6010
U.S. Securities and Exchange Commission
Division of Corporation Finance
One Station Place
100 F Street, N.E.
Washington, D.C. 20549-6010
|
| RE: |
| Edwards Lifesciences Corporation |
|
|
|
| Form 10-K for the fiscal year ended December 31, 2006 |
|
|
|
| Filed March 1, 2007 |
|
|
|
| File No. 001-15525 |
Dear Mr. Cascio:
Set forth below are the comments from your letter dated November 23, 2007, with respect to the Edwards Lifesciences Corporation (the “Company”) Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2006, filed with the SEC on March 1, 2007 (the “Annual Report”), and the Company’s responses to those comments. Our responses include additional disclosures that we propose to include in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2007, which will be filed later this month.
Form 10-K for the Fiscal Year Ended December 31, 2006
Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 24
Purchased in-process Research and Development Expenses, page 31
SEC COMMENT
COMPANY RESPONSE
In future filings, the Company will provide better linkage of program names that have changed over time for those IPR&D programs that are being updated in the discussion of Research and Development Expenses. Future filings will continue to disclose the status of the Company’s efforts for completion of the R&D projects and the impact on the Company from any delays. The Company will include explanations of material variations between projected results and actual results and how failure to achieve projected results impacted (or will impact) future results and financial condition.
Financial Statements, page 51
Note 2, Summary of Significant Accounting Policies, page 59
Revenue Recognition, page 60
With respect to the following, please refer to Section II.F.3 of the November 30, 2006 Current Accounting and Disclosure Issues in the Division of Corporation Finance available on our website at http://www.sec.gov/divisions/corpfin/cfacctdisclosureissues.pdf.
SEC COMMENT
COMPANY RESPONSE
The Company’s major revenue-generating products, which will continue to be disclosed in future filings, are technology-based medical devices designed to treat advanced cardiovascular disease.
2
The Company’s Heart Valve Therapy products include tissue heart valves and heart valve repair products. The Critical Care products include hemodynamic monitoring equipment used to measure a patient’s heart function, disposable pressure transducers, and the Company also provides central venous access products for fluid and drug delivery. The Company’s Cardiac Surgery Systems products include a diverse line of products for use during cardiac surgery including cannula, the Embol-X intra-aortic filtration product, certain other disposable products used during cardiopulmonary bypass procedures and, until March 2007, transmyocardial revascularization (TMR) products. (The TMR product line was sold in March 2007.) The Vascular products include a line of balloon catheter-based products, surgical clips and inserts, artificial implantable grafts and, through early 2008, stents used in the treatment of peripheral vascular disease. (The stent product line was sold in early 2008.) Lastly, the Company’s Other Distributed Products include intra-aortic balloon pumps sold through the end of 2007 (at which time the Company terminated its distribution rights for the sale of intra-aortic balloon pumps).
The technology referred to on page 59 is utilized in the development of these products and is not a separate offering by the Company. Accordingly, the technology does not represent a separate unit of accounting.
SEC COMMENT
COMPANY RESPONSE
As described above in the Company’s response to Comment #2, the technology is not a separate unit of accounting from the Company’s product sales.
SEC COMMENT
COMPANY RESPONSE
The Company’s sales terms are standard terms within the medical device industry, with title and risk of loss transferring to the customer upon delivery, limited right of return, and no unusual provisions or conditions. Certain of the Company’s products are sold under a consignment model whereby title and risk pass upon the customer’s use of the product. Payment terms in the Company’s major markets average 30 to 60 days in the U.S., 30 to 45 days in Europe and 100 days in Japan. Total sales adjustments (including rebates, charge-backs, returns and allowances) were approximately 8%-10% of gross
3
revenue in each of the last three years. These sales adjustments are estimated and recorded at the time of sale based upon historical payment experience, historical relationship to revenues, estimated customer inventory levels and current contract sales terms with direct and indirect customers.
The Company’s primary sales adjustment relates to distributor rebates (or “charge-backs”) which are given to the Company’s U.S distributors and represents the difference between the Company’s sales price to the distributor (at the Company’s distributor “list price”) and the negotiated price to be paid by the end-customer. This distributor rebate is recorded by the Company as a reduction to sales and reduction to the distributor’s accounts receivable at the time of sale to a distributor. The Company validates the distributor rebate accrual quarterly through a review of the inventory reports obtained from our largest distributors. This customer inventory information is used to verify the estimated liability for future distributor rebate claims based on historical rebates and contract rates. The Company continually monitors current pricing trends and distributor inventory levels to ensure the liability for future distributor rebates is fairly stated.
The Company also offers volume rebates to certain group purchasing organizations (“GPO”) and customers based upon target sales levels. These volume rebates are recorded as a reduction to sales and an obligation to the GPO. The provision for volume rebates is estimated based on our customers’ contracted rebate programs and our historical experience of rebates paid. The Company continually monitors its customer rebate programs to ensure that the liability for accrued rebates is fairly stated. Product returns are minimal because returns are not allowed unless the product is damaged at time of receipt. An allowance for return of damaged products is established based on historical experience and recorded as a reduction of sales.
In future filings, the Company will disclose the essential terms of the Company’s sales, including payment terms and unusual provisions or conditions, as appropriate.
SEC COMMENT
COMPANY RESPONSE
The Company recognizes revenue upon delivery of product (FOB destination), provided that an agreement of sale exists, the price is fixed or determinable, and collection is reasonably assured.
The Company previously had one product line (TMR products) for which the terms of sales included an acceptance provision. Previously, revenue was recognized at the time of customer acceptance for this product line. This product line represented approximately 1% of the Company’s total revenue in each of the past three years, and was divested in the first quarter of 2007. Accordingly, the Company will eliminate reference to an acceptance provision in future filings.
4
SEC COMMENT
COMPANY RESPONSE
The Company’s only multiple-element revenue arrangements were related to the TMR product line (described above in the Company’s response to Comment #5). The separate elements included in certain TMR transactions included capital equipment, extended warranties and disposable kits, each of which were also sold separately by the Company. This product line represented approximately 1% of the Company’s revenue in each of the past three years, and was divested in the first quarter of 2007. Accordingly, the Company will eliminate reference to multiple-element arrangements in future filings.
Controls and Procedures, page 105
SEC COMMENT
COMPANY RESPONSE
See response to Comment #8 below.
5
SEC COMMENT
COMPANY RESPONSE
In future filings, the second paragraph of Item 9A will read as follows (additional language is underlined):
Based on their evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures are designed at a reasonable assurance level and are effective in providing reasonable assurance that the information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, including the Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Exhibits 31.1 and 31.2
SEC COMMENT
COMPANY RESPONSE
In future filings, paragraphs 4(b) and 4(d) of Exhibits 31.1 and 31.2 will be in the exact form of Item 601(b)(31) of Regulation S-K.
* * *
6
The Company acknowledges that:
· it is responsible for the adequacy and accuracy of the disclosure in the filing;
· staff comments or changes to disclosure in response to staff comments in the filings reviewed by the staff do not foreclose the Commission from taking any action with respect to the filing; and
· the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
If you have any questions regarding the foregoing, please contact the undersigned at 949.250.6865 (facsimile: 949.756.4575) or Jay Wertheim at 949.250.6815 (facsimile: 949.250.6885).
|
Sincerely, |
/s/ Thomas M. Abate |
Thomas M. Abate |
Corporate Vice President, |
Chief Financial Officer and Treasurer |
7