SEC Company Response from ev3 Inc. (CIK 0001318310) — May 10, 2005
ev3 Inc. (CIK 0001318310)
Date: May 10, 2005 · CIK: 0001318310 · Accession: 0001047469-05-014171
AI Filing Summary & Sentiment
File numbers found in text: 333-123851
Referenced dates: April 29, 2005
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CORRESP
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filename1.htm
1185 Avenue of the Americas
New York, New York 10036-4003
Telephone: 212/556-2100
Fax: 212/556-2222
www.kslaw.com
Tracy Kimmel
Direct Dial: 212/556-2294
tkimmel@kslaw.com
May 10,
2005
Securities
and Exchange Commission
Division of Corporation Finance
Mail Stop 0409
Washington, D.C. 20549
Attention:
Peggy Fisher
Assistant Director
Alan Morris
Re:
ev3 Inc.
Registration Statement on Form S-1 filed April 5, 2005
File No. 333-123851
Ladies
and Gentlemen:
On
behalf of ev3 Inc. (the "Company"), we are delivering (and transmitting via EDGAR) with this letter for filing under the Securities Act of 1933, as amended (the "Securities
Act"), with the Securities and Exchange Commission (the "Commission") the following:
•Amendment
No. 1 ("Amendment No. 1") to the Registration Statement on Form S-1 (File No. 333-123851) (the "Registration
Statement"), together with the exhibits thereto; and
•Amendment
No. 1, without exhibits, marked to show changes from the Registration Statement on Form S-1 filed on April 5, 2005 (the "Original
Registration Statement").
We
are responding to the Staff's comments contained in its letter dated April 29, 2005. For your convenience, this letter sets forth in italics each of the Staff's comments before
each response.
Form S-1
Prospectus Summary—Page 1
1. Please confirm that any preliminary prospectus you circulate will include all non-Rule 430A information. This includes the price range and
related information based on a bona fide estimate of the public offering within that range. Also note that we will have additional comments after you include this and other missing
information.
Response: The Company confirms that any preliminary prospectus that is circulated to potential investors will contain all
non-Rule 430A information, including a range of estimated initial public offering prices and related information.
2. Revise the third paragraph of the prospectus summary and elsewhere throughout the filing to accurately reflect the history of the registrant. We note footnote 2
on page F-9. Quantify the roles of Warburg Pincus and The Vertical Group, Inc., and their current and previous equity and other interests in the registrant. Also explain in more
detail the registrant's relationship with MTI and the extent to which the registrant's revenues are attributable to MTI operations.
Response: The disclosure in the prospectus summary on pages 1-2 of Amendment No. 1 has been revised as
requested. See also pages 47-48 and 73. With respect to the interests of Warburg Pincus LLC and certain of its affiliates ("Warburg Pincus") and The Vertical Group, L.P. and certain of its
affiliates ("The Vertical Group"), the disclosure in the prospectus summary under "Our Principal Stockholders" on pages 7-8 of Amendment No. 1 has been revised to quantify these
interests. See also pages 127-128 of Amendment No. 1.
3. Please define technical terms in the summary when they are first used, including:
•Embolic protection
•Thrombectomy
•Balloon angioplasty
•Liquid embolics
•PLAATO
•Atrial fibrillation
•Aneurysm
Response: The disclosure in Amendment No. 1 has been revised as requested. See pages 2-4 and 14.
4. Provide supplemental support for all industry and market statistics.
Response: We have attached in Annex A hereto the supplemental support
requested. In each case, we have circled and numbered the relevant industry or market statistic contained in Amendment No. 1 and have attached the supplemental support for such statistic behind
the corresponding tab.
Corporate Reorganization—Page 3
5. Due to the blanks in this discussion and the reverse split discussion, we will defer or comments on this section until the disclosure is complete. Ensure that
the discussion clearly states the value of what Warburg Pincus and The Vertical Group are giving up and what they are getting in each of these transactions.
Response: The shares of common stock of Micro Therapeutics, Inc. ("MTI") and demand notes will be exchanged for common
membership units of ev3 LLC and shares of common stock of the Company, respectively. The disclosure on pages 5-6 and 127-128 of Amendment No. 1 has been revised to
indicate that the exchanges are intended to result in Warburg Pincus and The Vertical Group receiving common membership units and common stock of equal value to the securities being contributed by
them.
6. Explain the business reasons for this series of transactions.
Response: The disclosure on pages 4 and 127 of Amendment No. 1 has been revised as requested.
Merger with ev3 LLC—Page 3
7. Disclose how many unit holders there are in ev3 LLC, identify the major holders, and quantify the extent of their ownership
interest.
Response: The disclosure on pages 5 and 128 of Amendment No. 1 has been revised as requested.
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Our Structure—Page 5
8. In the second chart, identify the major shareholders of ev3 Inc., and quantify their ownership interest after the reorganization transactions are
completed.
Response: The disclosure on page 7 of Amendment No. 1 has been revised as requested.
Risk Factors
9. Expand the first risk factor to quantify your members' deficit to date.
Response: The disclosure on page 13 of Amendment No. 1 has been revised as requested.
If third parties claim that we infringe…—Page 11
10. Discuss under a separate caption the instances where you have been notified by other parties about potential infringement claims, beginning in the middle of
page 12.
Response: The disclosure on pages 14-15 of Amendment No. 1 has been revised as requested.
We may experience conflicts of interest…—Page 16
11. Expand the first paragraph to clarify that your current board of directors is comprised of seven members, four of which are also members of MTI's board of
directors. Identify the four directors.
Response: The disclosure on page 18 of Amendment No. 1 has been revised as requested.
Capitalization Table—Page 38
12. Please remove the cash and cash equivalent caption from this table.
Response: The disclosure on page 41 of Amendment No. 1 has been revised as requested.
Management's Discussion—Page 44
Overview—Page 44
13. Quantify the percentage of the registrant's revenues and net losses that are attributable to MTI.
Response: The disclosure on page 47 of Amendment No. 1 has been revised as requested. We note that while MTI makes up
a substantial majority of the Company's neurovascular segment, its results are not identical to such segment.
Results of Operations—Page 47
Comparison of Year Ended December 31, 2004 to Year Ended December 31, 2003—Page 48
14. Unless insignificant, please expand to quantify the effect of changes in prices on reported revenues. In general, your discussion should separately describe
and quantify the effects of price changes and sales volumes on reported revenues.
Response: We advise the Staff that the Company's net sales growth to date has been primarily the result of new product
introductions and increased volume as a result of sales force expansions and acquisitions. The Company believes that price changes have had an insignificant effect on the Company's net sales.
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Liquidity and Capital Resources—Page 53
15. Please expand the discussion of liquidity and capital resources to address any material acquisitions.
Response: The disclosure on pages 59-60 of Amendment No. 1 has been revised as requested.
16. Please significantly expand your disclosures to discuss your financing arrangements with MII, MTI, Warburg Pincus and The Vertical Group. Your attention is
invited to the disclosure requirements of SFAS 57.
Response: The disclosure on page 59 of Amendment No. 1 has been revised to discuss in more detail the financing
arrangements between ev3 Endovascular, Inc. ("ev3 Endovascular"), the Company's operating subsidiary, and Warburg Pincus and The Vertical Group. We note that the Company has no financing
arrangements with Micro Investment, LLC ("MII") or MTI.
MTI Financings and Liquidity—Page 56
17. The reference to "continuing cash from operations" as a source of liquidity for MTI is unclear in light of disclosure elsewhere that you expect operations to
consume cash in 2005. Please revise or advise.
Response: We have removed the reference to "continuing cash from operations" on page 64 of Amendment No. 1.
Critical Accounting Policies and Estimates—Page 57
18. What consideration have you given to disclosing your inter-company transaction policies under this heading?
Response: The Company has reviewed its inter-company transaction policies in light of the Staff's comment. The Company notes
that all inter-company transactions are eliminated in its combined consolidated financial statements and separate legal entity financial statements are not required in the Company's financial
reporting. Further, there is a formal process in place by which all inter-company agreements between ev3 LLC, Micro Investment, LLC and ev3 Endovascular and its subsidiaries, on the one hand, and MTI
and its subsidiaries, on the other hand, are reviewed and approved by a special independent committee of the board of directors of MTI, and the compliance under these agreements is reviewed at least
annually by this committee. The Company does not believe its inter-company
transaction policies require the application of significant judgment by management nor does it believe that any estimates inherent in the policies are subject to a high degree of uncertainty.
Consequently, the Company does not believe that these policies rise to the level of a critical accounting policy. In addition, the Company believes that these transactions are appropriately disclosed
in "Certain Relationships and Related Party Transactions-Transactions with MTI" on pages 131-134 of Amendment No. 1.
19. We note that you used a "third party appraisal" to value the in-process research and development acquired in 2002. If you elect to make such a
reference, please note that you will be required to identify the appraisal firm under "Experts" and include their consent in your registration statement. We will not object if you wish to indicate
(instead) that management considered an appraisal when estimating fair values.
Response: The disclosure on page 67 of Amendment No. 1 has been revised to indicate that management considered
an appraisal in determining the valuation of in-process research and development.
Peripheral Vascular Market Opportunity Business—Page 69
20. Please revise to describe the typical applications of your peripheral stents. We note the only application mentioned is the carotid artery. Are your stents
approved for other uses?
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Response: The disclosure on page 78 of Amendment No. 1 has been revised as requested. A summary of the approved uses
for the Company's peripheral stents is set forth on page 79 of Amendment No. 1.
Clinical Studies—Page 85
21. Please explain the term "primary endpoint."
Response: The disclosure on page 92 of Amendment No. 1 has been revised as requested.
Government Regulation—Page 90
Other Regions—Page 96
22. If material to your current or future sales, please describe the regulatory system in Japan.
Response: Although not material to the Company's historical net sales to date, the Company anticipates that its sales in
Japan will be material to its future net sales. Consequently, the Company has revised the disclosure on pages 103-104 of Amendment No. 1 to include a description of the regulatory
system in Japan.
Intellectual Property Rights—Page 100
23. If material, describe patent expirations.
Response: The disclosure on page 109 of Amendment No. 1 has been revised to describe the range of expiration dates of
the Company's material patents.
Management—Page 104
24. Please add the business experience information for Patrick D. Spangler.
Response: The disclosure on page 114 of Amendment No. 1 has been revised as requested.
25. With regard to Mr. Adams, please explain the terms "CAPLA" and "vascular brachy therapy."
Response: The disclosure on page 114 of Amendment No. 1 has been revised to remove the reference to "CAPLA" and to
explain the term "vascular brachy therapy" as requested.
26. With regard to Ms. Hines, please disclose her principal occupation during the period April 2000 -
January 2002.
Response: As disclosed on page 114 of Amendment No. 1, Ms. Hines was a consultant to ev3 LLC from
July 2001 to January 2002. Ms. Hines was on a hiatus from the medical device industry between April 2000 and July 2001 in order to pursue other
non-employment related interests.
27. With regard to Mr. Dale Spencer, please disclose his principal occupation during the past five years.
Response: During the past five years, Mr. Spencer's principal occupation has been as a private investor. The
disclosure on page 116 of Amendment No. 1 has been revised accordingly.
Option Grants in 2004—Page 112
28. Disclose how the reverse split will affect the number of options outstanding.
Response: The disclosure on pages 120-121 of Amendment No. 1 has been revised as requested.
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Employment Agreements—Page 113
29. Please describe the terms of your basic employment agreements, such as salary, bonus, options, term of office, etc., with the named executive
officers.
Response: The Company has disclosed the material terms of all of its agreements with the named executive officers. See pages
122-124 of Amendment No. 1. The Company does not have any other contractual obligations concerning salary, bonus, options or terms of office with respect to the named executive
officers.
Stock Plans—Page 115
Predecessor Plan—Page 115
30. Revise to clarify how exercise prices of assumed options will be determined.
Response: The disclosure on page 125 of Amendment No. 1 has been revised as requested.
2005 Incentive Stock Plan—Page 116
31. Revise to disclose whether options and rights may be granted at exercise prices less than 100% of market price at date of grant and how exercise prices will be
determined.
Response: The disclosure on page 126 of Amendment No. 1 has been revised as requested.
32. State whether options will be qualified under tax rules.
Response: The disclosure on page 126 of Amendment No. 1 has been revised as requested.
Certain Relationships and Related Party Transactions—Page 118
Corporate Reorganization—Page 118
33. Please revise to clarify at what point the reverse split will occur, and the effect thereof on the number of shares of stock the affiliates will own after the
offering.
Response: The disclosure on pages 4, 6 and 127-128 of Amendment No. 1 has been revised as requested.
34. When blanks are filled in, we will comment further on this section.
Response: The Company intends to complete this information when it files a pre-effective amendment to the
Registration Statement setting forth a range of estimated initial public offering prices and the ratio for the reverse stock split.
Principal and Selling Stockholders—Page 126
35. Identify the persons who have or share voting and/or investment control over the shares held by the entities listed in the
table.
Response: Upon consummation of the reorganization transactions described in the Registration Statement, Warburg, Pincus
Equity Partners, L.P., a Delaware limited partnership (together with two affiliated partnerships, the "Warburg Pincus partnerships"), will be the record owner of the shares of the Company's common
stock indicated as beneficially owned by Warbur