SEC Company Response from IDEXX LABORATORIES (IDXX) — Jun 11, 2010
IDEXX LABORATORIES INC /DE (IDXX) (CIK 0000874716)
Date: June 11, 2010 · CIK: 0000874716 · Accession: 0000874716-10-000016
AI Filing Summary & Sentiment
File numbers found in text: 000-19271
Referenced dates: May 20, 2010
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CORRESP
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June 11, 2010
Jeffrey P. Riedler
Assistant Director
Division of Corporation Finance
United States Securities and Exchange Commission
Re: IDEXX Laboratories, Inc.
Form 10-K for Fiscal Year Ended December 31, 2009
Filed on February 19, 2010
File No. 000-19271
Dear Mr. Riedler:
Please see our responses below to your letter dated May 20, 2010. Each of our responses is preceded by a reproduction of the corresponding numbered Staff comment.
In connection with responding to the Staff’s comments, we acknowledge that:
·
We, the Company, are responsible for the adequacy and accuracy of the disclosure in the filings;
·
Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and
·
We, 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.
Form 10-K December 31, 2009
Item 1. Business
Production and Supply, page 9
Comment:
1.
You have disclosed that you purchase some products, raw materials and components from a single supplier. Please identify your sole source suppliers, describe the material terms of the supply agreement and file the agreements as exhibits. To the extent you believe you are not substantially dependent on these agreements, please provide your analysis supporting your determination.
Mr. Jeffrey P. Riedler
United States Securities and Exchange Commission
June 11, 2010
Page 2
Response:
As described in the Business section of our 2009 Form10-K, some of the third parties that provide us with instruments we sell and certain components, raw materials and consumables incorporated into, or used with, our products are obtained from sole or single source suppliers. We define sole source suppliers as those third party suppliers that provide a raw material, component, or product for which we have not identified any other viable supplier. We define single source suppliers as those third party suppliers from which we elect to purchase all of our supplies of a particular raw material, component, or product that is also available from one or more other viable suppliers.
We believe that we are not substantially dependent on any of our single source suppliers because, in the event of a significant disruption in supply of raw materials, components, or products by such a supplier, we would be able to source equivalent raw materials, components, or products from alternative suppliers in a commercially reasonable time frame without disruption to our business.
We currently have eight sole source suppliers. With respect to four of such suppliers, 2009 revenues from the sale of products supplied by such suppliers or from the sale of products incorporating raw materials or components supplied by such suppliers, as the case may be, were less than 1% of our 2009 worldwide sales. With respect to two of such suppliers, such revenues were between 1% and 1.9% of our 2009 worldwide sales. Due to the immateriality of the relevant product sales to the Company as a whole, we believe that we are not substantially dependent on any of these six sole source suppliers and that any agreements with such suppliers need not be included as exhibits to our Form 10-K. Further detail concerning the remaining two sole source suppliers is provided below.
Ortho
We have agreements with Ortho-Clinical Diagnostics, Inc.(“Ortho”) for the supply of our VetTest® and Catalyst Dx® chemistry slides. We discuss this sole source relationship on page 9 of our 2009 Form 10-K and in our response to Comment #2 below. We have previously filed the agreements with Ortho as exhibits.
Moss
Moss, Inc. (“Moss”) is a sole source supplier of components that are incorporated into a number of our SNAP® single-use test kits. Sales of SNAP® kits incorporating these components in 2009 were approximately 17% of our 2009 revenues. While we do not believe all SNAP® revenue is dependent on the components obtained from Moss, or that we are “substantially dependent” on the Moss agreement as that term is used in Item 601(b)(10)(ii)(B) of Regulation S-K, in future filings, beginning with the 10-Q for the second quarter of 2010, we will include our agreement with Moss as an exhibit. In future Form 10-K filings, beginning with the Form 10-K for the
Mr. Jeffrey P. Riedler
United States Securities and Exchange Commission
June 11, 2010
Page 3
2010 fiscal year, we will include disclosure of the material terms of the Moss agreement, which are described in the following paragraph.
The supply agreement with Moss may be terminated by Moss with 24 months’ notice. We are required annually to purchase a minimum amount from Moss equal to our average purchase volumes in 2004, 2005 and 2006. Annual pricing increases are capped at 3%. Pursuant to the terms of the supply agreement, Moss has escrowed its manufacturing information relating to the components, which may be released to us upon certain triggering events that would render Moss incapable of supplying the components to us. If such a triggering event occurs, we will make royalty payments to Moss for the use of such information until Moss is able to again begin manufacturing.
Comment:
2.
Please describe the material terms of your supply agreements with Ortho-Clinical Diagnostics, Inc.
Response:
As noted on page 9 of our 2009 Form 10-K, we have agreements with Ortho for the supply of slides used in our chemistry analyzers that expire in 2025. We are required to purchase a minimum volume of chemistry slides through the end of 2010; thereafter, we do not have minimum purchase obligations. Price increases for slides are limited by a formula based on an agreed U.S. Producer Price Index. The agreements limit the rights of Ortho to promote and sell chemistry slides in the veterinary market other than to IDEXX. In future Form 10-K filings, beginning with the Form 10-K for the 2010 fiscal year, we will include this additional disclosure regarding the material terms of the Ortho agreement.
Patents and Licenses, page 9
3.
Please identify the products or classes of products related to patents related to the detection of Lyme disease and the detection of FIV antibodies.
Response:
As supplemental information, we advise the Staff that the products that utilize the patented technology for the detection of Lyme disease are SNAP® 3DX® and SNAP® 4DX®. In addition, our reference laboratories offer a test called Lyme Quant C6® that utilizes this technology.
As supplemental information, we advise the Staff that the products that utilize the patented technology for detecting FIV antibodies are SNAP® Feline Triple®; SNAP® FELV/FIV Combo; and SNAP® Feline Combo Plus.
Mr. Jeffrey P. Riedler
United States Securities and Exchange Commission
June 11, 2010
Page 4
4.
Please describe the material terms of your agreements with Tulane University, the University of Texas, Boehringer Ingelheim and Cornell University and identify the products or class of products related to these license agreements. Please either file these agreements as exhibits or provide us with an analysis supporting your determination that you are not substantially dependent of these agreements.
Response:
The products or laboratory tests that utilize the intellectual property covered by the agreements with Tulane University (“Tulane”) and the University of Texas (“Texas”) are Lyme Quant C6®, SNAP® 3DX® and SNAP® 4DX®. Aggregate sales of these products and tests did not exceed 7% of the Company’s 2009 worldwide sales. In addition, the SNAP® 3DX® and SNAP® 4DX® products test for three and four vector-borne diseases, respectively, only one of which (Lyme disease) utilizes the Tulane and Texas intellectual property. A significant portion of the customer value associated with the SNAP® 3DX® and SNAP® 4DX® tests, therefore, is the detection of diseases other than Lyme disease, including canine heartworm, by means unrelated to the Tulane and Texas intellectual property. For this reason we believe that the significance of the Tulane and Texas intellectual property to us is significantly overstated by analyzing aggregate revenues from the sale of these products relative to our total sales. Nonetheless, even using this very conservative approach of looking at total revenue for all three products, we believe that we are still not substantially dependent on the agreements with Tulane and Texas, and that the agreements do not need to be included as exhibits to the Form 10-K.
The products that utilize the intellectual property covered by the agreement with Boehringer Ingelheim (“Boehringer”) are our porcine reproductive and respiratory test kits. Sales of these test kits did not exceed 1% of our 2009 worldwide sales. Therefore, we believe that we are not substantially dependent on the agreement with Boehringer and that such agreement need not be included as an exhibit to the Form 10-K.
The products that utilize the intellectual property covered by the agreement with Cornell University (“Cornell”) are our bovine viral diarrhea virus test kits. Sales of these test kits did not exceed 1% of our 2009 worldwide sales. Therefore, we believe that we are not substantially dependent on the agreement with Cornell and that such agreement need not be included as an exhibit to the Form 10-K.
Government Regulation, page 11
Comment:
5.
We note your statement that “compliance with an extensive regulatory process is required in connection with marketing diagnostic products in Japan, Germany, the Netherlands and many other countries.” Please expand your disclosure to include a more detailed discussion of the regulatory processes in those countries and others outside the United States where you currently market your products, to the extent that your sales in these countries are material.
Mr. Jeffrey P. Riedler
United States Securities and Exchange Commission
June 11, 2010
Page 5
Response:
Our total sales of regulated products in any country other than the United States did not exceed 3% of our 2009 worldwide sales, which we do not consider to be material. Accordingly, we do not believe any further disclosure regarding foreign regulatory processes is necessary at this time.
Item 1A. Risk Factors
Various Government Regulations Could Limit or Delay Our Ability to Market and Sell Our Products, page 14
6.
To the extent known, please expand your disclosure concerning the FTC’s investigation to state the actual practices you have engaged in that are at issue, including which products they concern, and what potential penalties you will be subject to if the FTC concludes that you have violated Section 5 of the Federal Trade Commission Act.
Response:
The FTC’s investigation is at an early stage and our disclosure regarding the scope of the investigation reflects our knowledge based on correspondence and discussions to date with the FTC. At this time we are unable to describe the actual practices that are at issue with any further specificity because, to our knowledge, the FTC has not focused its investigation on particular practices beyond what we have disclosed in the risk factor.
Similarly, with respect to the relevant products, at this time we understand that the FTC is looking at all companion animal veterinary products and services, as disclosed in the risk factor, and we cannot describe the relevant products with any further specificity. Our companion animal products and services are described in detail in the Form 10-K in the section entitled “Description of Business by Segment – Companion Animal Group.”
In any event, based on our understanding of the investigation, we have stated in the risk factor that we do not believe that any remedies that might be sought by the FTC, were the FTC to seek remedies following its investigation, would have a material adverse effect on the Company. The FTC’s remedies under section 5 of the FTC Act are prospective in nature, and we do not believe that our business is materially dependent on our ability to continue any one or more marketing and sales practices relating to companion animal products and services in the U.S.
Definitive Proxy Statement on Schedule 14A
Nominating and Governance Committee, page 8
Mr. Jeffrey P. Riedler
United States Securities and Exchange Commission
June 11, 2010
Page 6
7.
Your disclosure concerning diversity on page 9 does not include a discussion of how the Nominating and Governance Committee has implemented this policy or how the Committee assesses its effectiveness. Please revise your disclosure to include this information. We refer you to Item 407(c)(2)(vi) of Regulation S-K.
Response:
We do not have a formal policy on diversity for Board members. Our Corporate Governance Guidelines provide that the value of diversity will be considered when the Board evaluates nominees to the Board and the composition of the Board as a whole. In making the evaluations described in the prior sentence the Board also considers a range of other factors, including the experience, education, background, skills and knowledge of nominees and directors. The Board does not make any particular weighting of diversity or any other characteristic in evaluating nominees and directors.
In future proxy statements, as applicable, beginning with the proxy statement for our 2011 annual meeting of shareholders, we will make clear that we do not have a formal diversity policy for Board members, but that diversity is considered as described above.
Election of Directors, page 17
Comment:
8.
Please identify the specific experience, qualifications, attributes or skills that led to the conclusion that each person should serve as a director as required by Item 401(e) of Regulation S-K. Please note that your discussion on page 8 is not sufficient as the item requires a discussion of each individual’s experience, qualifications, attributes or skills, as opposed to a discussion of the board members’ collective experience, qualifications, attributes or skills.
Response:
We enhanced the biographies for each director in our 2010 proxy statement (beginning on page 17) in order to disclose the specific experience, qualifications, attributes and skills that led the Board to conclude that each person should serve as a director. For example, below are the biographies for William T. End, our lead director, from the 2009 proxy statement and the 2010 proxy statement. The 2010 biographical information contains significant additional information that is intended to be responsive to Item 401(e) of Regulation S-K.
On page 9 of our 2010 proxy statement, we stated that the Nominating and Governance Committee reviewed the experience, qualifications, attributes and skills for each director and nominee, as described for each director in his or her biography beginning on page 17, and concluded that each director had the requisite background to serve as a director in light of the
Mr. Jeffrey P. Riedler
United States Securities and Exchange Commission
June 11, 2010
Page 7
Company’s business and structure. We therefore believe that the 2010 proxy statement included the information required under Item 401(e).
Mr. End’s biography from 2009 proxy statement (page 15)
William T. End, age 61, has been a director of IDEXX since July 2000. Mr. End was the Executive Chairman of the Board of Cornerstone Brands, Inc., a catalog retailer, from March 2001 until his retirement in June 2002, and served as Chairman and Chief Executive Officer of Cornerstone Brands, Inc. from 1995 until March 2001. From 1991 to 1995, Mr. End was employed by Land’s End, Inc., including as President and Chief Executive Officer, and from 1975 to 1991 he was employed by L.L. Bean, Inc., including as Executive Vice President. Mr. End is a director of Eddie Bauer