corresp
April 28, 2006
VIA EDGAR
Mr. Larry Spirgel
Assistant Director
Securities and Exchange Commission
Division of Corporate Finance
450 Fifth Street, N.W.
Washington, D.C. 20549
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RE:
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SurModics, Inc. |
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Form 10-K for fiscal year ended September 30, 2005 |
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Form 10-Q for the quarter ended December 31, 2005 |
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File No. 000-23837 |
Dear Mr. Spirgel:
This letter is being filed to respond on behalf of SurModics, Inc. (the Company) to the
comments raised by your letter dated April 7, 2006 regarding the above-referenced filings. For
ease of reference, we have included each of your comments followed by the Companys responses.
Form 10-K for the fiscal year ended September 30, 2005
Item 7 managements Discussion and Analysis, Page 24
Results of Operations, page 27
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SEC COMMENT: In your discussion of revenues on page 34, you attribute the change to
several factors, without quantifying or indicating the relevant weight of each factor. For
example, you mention significant growth in royalties and license fees for both Drug
Delivery and Hydrophilic operating segments, but you do not quantify the increase or
indicate the reasons for the increase. Therefore, if material, provide a discussion of the
components of revenue growth (e.g. volume of licenses, royalty fees, acquisitions, etc.) by
operating segment or business unit for all periods presented. Further, with respect to
your |
Mr.
Larry Spirgel
April 28, 2006
Page 2
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explanations amend to provide insight into the underlying business drivers or conditions
that contributed to theses changes. Please refer to Item 303 of Regulation S-K and the
Commissions interpretive Release on Managements Discussion and Analysis of Financial
Condition and Results of Operation on our website at:
http://www.sec.gov/rules/interp/33-8350.htm. |
COMPANY RESPONSE: Beginning with the March 2006 Form 10-Q, the Company plans to more
thoroughly discuss the material components of revenue growth and provide insight into
the underlying business drivers or conditions that contributed to material changes.
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SEC COMMENT: We refer to your January 18, 2005 purchase of assets and related
technology of InnoRx, which you characterize as a development stage company. In accordance
with Rule 11-01(d) of Regulation S-X, tell us how you determined whether or not there is
sufficient continuity of operations, as the disclosure of prior financial information may
well be material to an understanding of the future operations of your company. |
COMPANY RESPONSE: As part of the Companys process of determining whether or not
subsequent to our purchase of InnoRx, Inc. there was sufficient continuity of
operations of InnoRx, we relied on much of the same analysis we completed in
determining whether the purchase itself resulted in the receipt of productive assets
or of a business. InnoRx was founded by a medical doctor with the intent of
commercilizing his ideas for treating diseases of the back of the eye. The only
employees of InnoRx were a general manager and his administrative assistant. The
general manager worked toward forming financial and technical alliances to further
the progress of the founders ideas around treatments for eye disease. Both
individuals worked out of an office in Alabama. The founder was an employee of the
University of Southern California and worked out of the institute he headed there.
The nature of the operating activities at this early stage was limited to proving the
founders concept, i.e., early engineering prototyping and simple animal studies.
Upon reaching completion of these early stage engineering and animal studies efforts,
the Company initiated discussions about purchasing InnoRx and advancing development
to the next stage: pursuing U.S. Food and Drug Administration (FDA) approval of the
ophthalmic implant through human clinical trials.
In our analysis of whether the purchase itself resulted in the receipt of productive
assets or of a business, we relied on the guidance provided by EITF 98-3. In
paragraph 6, a business is described as a self-sustaining integrated set of
activities
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Mr.
Larry Spirgel
April 28, 2006
Page 3
and assets conducted and managed for the purpose of providing a return to investors.
Paragraph 6 further states that for a transferred set of activities and assets to be
a business, it must contain all the inputs and processes necessary for it to continue
to conduct normal operations after the transferred set (inputs, processes, and
outputs) is separated from the transferor, which includes the ability to sustain a
revenue stream. At the time of the Companys purchase of InnoRx, the inputs
consisted of the two employees, neither of whom was working on development of the
implant or the intellectual property created to that point. Processes and outputs,
the second and third components of the necessary integrated set of activities were
non-existent as there were no operations per se (activities revolved around
developing the device, not manufacturing of the device), and no output as there were
no customers and no FDA approved product to sell. The Company determined that the
missing elements required a high degree of difficulty and level of investment such
that the elements acquired in the purchase did not constitute a business. Hence the
merger was treated as a purchase of assets.
Similarly, in making our assessment of continuity of operations with respect to Rule
11-01(d) of Regulation S-X, we analyzed the facts involved against the criteria in
Rule 11-01(d) and determined that disclosure of financial information was neither
material nor relevant to an understanding of future operations.
The operations of InnoRx to that point were limited to small scale prototype design,
proof of concept, and raising capital. Following the Companys purchase of InnoRx,
the next stage of development was to conduct human clinical trials. Clinical trials
require specialized talent costing millions of dollars and are conducted over several
years. Subsequent to the purchase of InnoRx, the Alabama office was closed, and
neither of the two employees was offered employment. Since none of the activities
being performed at the time of the Companys purchase of InnoRx and none of the
operational costs at the time were indicative of the activities or investment
required for the clinical trial phase, we determined that operations subsequent to
our acquisition would be significantly different. While we plan to further develop
the technology purchased, we do not believe the historical operations of InnoRx would
be meaningful to users of our financial statements to understand our future
operations.
Finally, the Company acknowledges that it is responsible for the adequacy and accuracy of the
disclosure in its 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 filings; 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.
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Mr.
Larry Spirgel
April 28, 2006
Page 4
If you have any questions regarding this letter, please contact me at (952) 829-2715 so that I
may respond promptly.
Very truly yours,
Philip D. Ankeny
Chief Financial Officer
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