SEC Company Response from ATS MEDICAL INC (CIK 0000824068) — Nov 29, 2005
ATS MEDICAL INC (CIK 0000824068)
Date: Nov. 29, 2005 · CIK: 0000824068 · Accession: 0000950134-05-022323
AI Filing Summary & Sentiment
File numbers found in text: 000-18602
Referenced dates: October 31, 2005
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[ATS Medical, Inc. Letterhead]
November 29, 2005
VIA EDGAR SUBMISSION
--------------------
Mr. Brian Cascio
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington DC, 20549
Re: ATS Medical, Inc.
Form 10-K for the Year Ended December 31, 2004
Filed March 14, 2005
Form 10-Q for the Quarterly Periods Ended March 31, 2005 and
June 30, 2005 File No. 000-18602
Dear Mr. Cascio:
Under cover of this letter, Dorsey & Whitney LLP, counsel to ATS Medical,
Inc. (the "Company"), is transmitting a letter responding to the comments
received by the Company from you on behalf of the Division of Corporation
Finance of the Securities and Exchange Commission (the "Commission"), in a
letter dated October 31, 2005 (the "Comment Letter"). As requested in the
Comment Letter, the Company hereby acknowledges the following statements:
o The Company is responsible for the adequacy and accuracy of the
disclosure in its filings;
o Staff comments, and changes made to the Company's disclosure in its
filings in response to staff comments, do not foreclose the Commission
from taking any action with respect to the Company's filings; and
o 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 above, please contact the
undersigned at (763) 557-2222 or by fax at (763) 553-0052.
Very truly yours,
/s/ John R. Judd
John R. Judd
Chief Financial Officer
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[Dorsey & Whitney Letterhead]
TIMOTHY S. HEARN
Partner
(612) 340-7802
FAX (612) 340-8738
hearn.tim@dorsey.com
November 29, 2005
VIA EDGAR SUBMISSION
Mr. Brian Cascio
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington DC, 20549
Re: ATS Medical, Inc.
Form 10-K for the Year Ended December 31, 2004
Filed March 14, 2005
Form 10-Q for the Quarterly Periods Ended March 31, 2005 and
June 30, 2005 File No. 000-18602
Dear Mr. Cascio:
On behalf of ATS Medical, Inc., a Minnesota corporation (the "Company"),
this letter responds to the comments received from you on behalf of the Division
of Corporation Finance of the Securities and Exchange Commission (the
"Commission"), in a letter dated October 31, 2005 (the "Comment Letter"). For
ease of reference in this letter, the Commission's comments contained in the
Comment Letter appear directly above the Company's response.
FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2004
Results of Operations, page 16
------------------------------
Cost of Goods Sold, page 17
---------------------------
1. Comment:
We note that your MD&A discussion includes Non-GAAP measures called
"Adjusted cost of goods sold" and "Adjusted cost of goods sold as a percentage
of net sales." Please tell us how these measures comply with the guidance
provided in SEC Rule 34-47226 -- Conditions for Use of Non-GAAP Financial
measures or the Staff's FAQ Regarding the use of Non-GAAP Financial Measures
since they clearly exclude recurring items. Please refer to Questions 8 and 9 of
the FAQ.
Response:
As noted in the comment, the Company's Form 10-K for the year ended
December 31, 2004 (the "2004 Form 10-K") included two non-GAAP financial
measures, namely "adjusted
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Securities and Exchange Commission
November 29, 2005
Page 2
cost of goods sold" and "adjusted cost of goods sold as a percentage of net
sales," in its MD&A. Each of these measures was adjusted to remove the impact of
certain lower of cost or market charges included in the GAAP measure "cost of
goods sold." In response to this comment we have reviewed the cited materials
and other materials relating to the use of non-GAAP financial measures. The
Company believes that the exclusion of these lower of cost or market adjustments
is appropriate because the Company anticipates that these adjustments will
diminish substantially in the near future. Historically, the Company has taken
lower of cost or market inventory adjustments because its inventory consisted
largely or entirely of high-cost heart valve components purchased under its
Carbomedics supply agreement and a large percentage of its sales of heart valves
was in foreign markets with depressed pricing. With the suspension of purchases
under the supply agreement in 2002 and the commencement of manufacturing its own
lower-cost heart valve components in 2004 the Company has steadily reduced its
inventory of high-cost components to the point that it expects its inventory and
sales levels to be in balance in 2006. At the same time the Company's sales of
valves in the higher-priced U.S. market have increased. As a result, the Company
anticipates that it will record few if any lower of cost or market inventory
adjustments in future periods.
In light of this comment and the materials cited in the comment, the
Company significantly expanded its disclosure with respect to these non-GAAP
financial measures in its recently filed Form 10-Q for the quarter ended
September 30, 2005 (the "Third Quarter 10-Q"). In particular, the Company
included the following paragraph in the "Cost of Goods Sold" section of the MD&A
in the Third Quarter 10-Q:
ATS reports its financial results in accordance with generally
accepted accounting principles ("GAAP"). In addition, from time to
time, we include other measures in our reports which are not prepared
in accordance with GAAP. Investors should consider these non-GAAP
measures in addition to, not as a substitute for or as superior to,
financial reporting measures prepared in accordance with GAAP. In the
above paragraph, we have included adjusted versions of our gross margin
percentages for the third quarters and first nine months of 2005 and
2004. These non-GAAP measures do not reflect a lower of cost or market
inventory adjustment in the third quarter of 2005 and certain factory
production ramp-up costs in the third quarter of 2004 because we
believe that these charges will not be incurred on a regular basis in
the future. Historically, we have taken lower of cost or market
inventory adjustments because our inventory consisted largely or
entirely of high-cost heart valve components purchased under our
Carbomedics Supply Agreement and a larger percentage of our sales of
heart valves was in foreign markets with depressed pricing. With the
suspension of purchases under the Supply Agreement in 2002 and the
commencement of manufacturing our own lower-cost heart valve components
in 2004 we have steadily reduced our inventory of high-cost components
to the point that we expect our inventory and sales levels to be in
balance in 2006. At the same time our sales of valves in the
higher-priced U.S.
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Securities and Exchange Commission
November 29, 2005
Page 3
market have increased. As a result, we anticipate that we will record
few if any lower of cost or market inventory adjustments in future
periods. Similarly, our factory production ramp-up costs recorded in
the third quarter of 2004 related to the launch and qualification of
our valve component manufacturing facility. Now that our manufacturing
facility is up and running we do not expect to incur such ramp-up
costs in future periods. We use the adjusted gross margin measure in
our internal analysis and review of our operational performance. We
believe that these non-GAAP measures provide investors with useful
information in comparing our performance over different periods,
particularly when comparing one of these periods to a period in which
we did not incur these kind of charges. By using these non-GAAP
measures we believe investors get a better picture of the performance
of our underlying business. The table below reconciles our gross
margin percentage calculated using numbers prepared in accordance with
GAAP to our adjusted gross margin percentages presented above.
In light of this comment, the Company plans to include similar disclosure when
appropriate in future filings.
Liquidity and Capital Resources, page 19
----------------------------------------
Cash Management, page 20
------------------------
2. Comment:
We see that you are required to resume purchasing carbon components
from Carbomedics under the supply agreement in 2007 through 2011. We also note
that the supply agreement was previously suspended in 2002 due to the
accumulation of the high priced inventory acquired from Carbomedics. You
disclose that as of December 31, 2004 you had not yet sold the entire inventory
acquired prior to 2002 and that the purchase commitments in 2007 will remain at
the same pricing level. In your response and in future filings, please discuss
how the minimum purchase commitments of the supply agreement will affect future
cash flows and inventory levels. Specifically, please address how you intend to
avoid the build up of inventory that occurred under the supply agreement in
2002.
Response:
In response to this comment the Company included the following
paragraph under the heading "Cash Management" in the "Liquidity and Capital
Resources" section of the MD&A in its Third Quarter 10-Q:
Our current obligations under the Carbomedics Supply Agreement
call for us to resume purchasing heart valve components from 2007
through 2011. Based on current forecasts, we expect these component
purchases to represent a small
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Securities and Exchange Commission
November 29, 2005
Page 4
percentage of our unit sales in those years. Before the suspension of
the Supply Agreement in 2002, Carbomedics supplied us with 100% of our
inventories and our purchase requirements under the Agreement often
significantly exceeded our sales. In 2004, we started manufacturing
our own valve components so we are no longer dependent on Carbomedics
as a sole supplier. Although our future purchase requirements under
the Agreement will be at a cost that is higher than our anticipated
manufacturing costs, the quantity of components purchased will be
significantly less than in previous years. We expect to be able to
adjust our manufacturing levels during this period to prevent the
build up of excess component inventories. Because the parts we
purchase from Carbomedics will be at a higher cost than our
self-manufactured product, our net income and cash flows in the
periods when the parts are sold will be lower; however we anticipate
that our business performance in those future periods will be adequate
to absorb these costs and cash flows.
The Company believes this disclosure responds to the comment above. In light of
this comment, the Company plans to include similar disclosure when appropriate
in future filings.
FORM 10-Q FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2005
Item 4. Controls and Procedures, page 19
-----------------------------------------
3. Comment:
We note that you had a material weakness in your disclosure controls
and procedures as of December 31, 2004 related to your inventory cycle counting
methods, as disclosed in your Form 10-K. As of March 31, 2005, you disclose that
your disclosure controls and procedures are effective. Please tell us and revise
future filings to clarify the changes made to correct the material weaknesses in
your disclosure controls and procedures as of March 31, 2005. Your filing should
disclose any changes made to your disclosure controls and procedures or to your
internal control over financial reporting in response to a significant
deficiency or material weakness. Please refer to Question 11 of the Frequently
Asked Questions for Management's Report on Internal Control over Financial
Reporting and Certification of Disclosure in Exchange Act Periodic Reports
located on the SEC website.
Response:
As disclosed in Item 9A of the 2004 Form 10-K, the Company concluded
that its disclosure controls and procedures were not effective at December 31,
2004 due to a material weakness in its internal control over inventory cycle
counting procedures. As disclosed in Item 9A of the 2004 Form 10-K and in Item 4
of the Company's Form 10-Q for the quarter ended March 31, 2005, the Company
addressed this material weakness in its internal control by conducting a
physical inventory during its first quarter rather than relying on its cycle
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Securities and Exchange Commission
November 29, 2005
Page 5
count procedures. Thus the change made to make the Company's disclosure controls
and procedures effective as of March 31, 2005 was that a physical inventory was
conducted instead of relying on the prior cycle counting procedure. In light of
this comment, the Company expanded its disclosure in Item 4 of the Third Quarter
10-Q to read as follows:
ITEM 4. CONTROLS AND PROCEDURES
As previously reported, in connection with our assessment of
the effectiveness of our internal control over financial reporting at
the end of our last fiscal year, we identified a material weakness in
our internal control over financial reporting. The deficiency in our
internal control related to ineffective application of inventory
verification procedures, including cycle count procedures.
Historically, we had relied on cycle counting procedure to substantiate
inventory quantities in lieu of taking physical inventories. During our
evaluation of internal control over our cycle counting procedures, we
determined that our processes in place during 2004 were neither
sufficient nor documented adequately to rely upon. Because of the
material weakness described above, management concluded that (i) the
Company did not maintain effective internal control over financial
reporting as of December 31, 2004, based on the criteria established in
"Internal Control - Integrated Framework" issued by COSO, and (ii) as a
result of this material weakness our disclosure controls and procedures
were not effective as of December 31, 2004.
To address this material weakness, commencing with the first
quarter of fiscal 2005 we instituted a practice of conducting periodic
physical inventories instead of relying on the cycle count procedure
previously in use. We relied on this physical inventory procedure when
our management concluded as of March 31, 2005 and June 30, 2005 that
our disclosure controls and procedures were effective. We will continue
to cond