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SEC Comment Letter for VERU INC. (VERU) (CIK 0000863894) (VERU) — Feb 25, 2010

VERU INC. (VERU) (CIK 0000863894)
Date: Feb. 25, 2010 · CIK: 0000863894 · Accession: 0000000000-10-010847

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Date
February 25, 2010
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UPLOAD
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VERU INC. (VERU) (CIK 0000863894)

Letter

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549-4631 DIVISION OF CORPORATION FINANCE Mail Stop 4631 February 25, 2010 Ms. Donna Felch The Female Health Company 515 N. State Street, Suite 2225 Chicago, IL RE: The Female Health Company Form 10-K for the fiscal year ended September 30, 2009 Filed December 17, 2009 File #1-13602

Dear Ms. Felch: We have reviewed your filings and have the following comments. Where indicated, we think you should re vise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as deta iled as necessary in your explanation. In some of our comments, we may ask you to pr ovide us with supplemental information so we may better understand your disclosure. Af ter reviewing this information, we may or may not raise additional comments. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Form 10-K for the fiscal year ended September 30, 2009

Item 1. Business

Strategy, page 7 1. In future filings, please describe you r relationship with Hindustan Lifecare Limited in greater detail. Please publicl y file any agreements between you and Hindustan Lifecare Limited that are material to your business.

Ms. Donna Felch The Female Health Company February 25, 2010 Page 2 Government Regulation, page 10

2. In future filings, please expand the discu ssion in the second paragraph to explain what you mean by, “FC2 received PMA as a Class III Medical Device.” In doing so, please explain what “PMA” means a nd explain the sign ificance of this classification. 3. In future filings, please expand the disc ussion in the third paragraph to state whether the company is in compliance w ith the conditions of the FDA’s approval order relating to the company’s sales and distribution of the FC2 products.

Item 7. Management’s Discussion and Analys is of Financial Condition and Results of Operations, page 18 Liquidity and Sources of Capital, page 24 4. We note your statement on page 25 that you believe your “current cash position is adequate to fund operations . . . in the n ear future.” In future filings, please expand your liquidity discussion to addr ess liquidity on both a long-term and short-term basis. To the extent you can do so, when providing guidance about your liquidity please use more precise pe riods (e.g., the next 12 months) rather than terms like “in the near future,” whose meaning is less clear. Please refer to Item 303(a)(1) of Regulation S- K and Instruction 5 thereto. 5. We note that you have two revolving notes with Heartland Bank. Please revise future filings to discuss the terms and conditions of any si gnificant covenants you are subject to under these notes. In a ddition, if you are subject to financial covenants, please revise future annual a nd quarterly filings to present, for the most significant and restrictive covenants, actual ratios and other actual amounts versus the minimum/maximum ratios/amounts required at each reporting date. Such a presentation may allow investor s to more easily assess and understand your current status and future ability to meet your covenants. See Sections I.D and IV.C of the SEC Inte rpretive Release No. 33-8350

Note 1. Nature of Business and Signif icant Accounting Policies, page F-7 Accounts receivable and concentra tion of credit risk, page F-7 6. Please revise future filings to disclose the percentages of sales to significant customers for each period presented. Re ference Item 101 of Regulation S-K and ASC 280-10-50-42.

Ms. Donna Felch The Female Health Company February 25, 2010 Page 3 Note 6 - Income Taxes, page F-14

7. With a view toward future disclosure, please provide us a more specific and comprehensive explanation of how you de termined changes in your tax valuation allowance during each period presented. Se parately address your ability to utilize U.S. and foreign carry-forwards.

Note 13 - Restructuri ng Costs, page F-23 8. With a view toward future disclosure , please provide us a more specific and comprehensive discussion of the nature of your restructuring costs. In this regard, please clarify your “redundancy” and “o ther expenses”. Reference ASC 420-10- 50. Also, please explain to us how you dete rmined the appropriate time period to accrue the restructuring costs that you recorded in FY 2009 and FY 2010.

Item 15. Exhibits and Financia l Statement Schedules, page 43 9. We note from your disclosure in the Management’s Discussion and Analysis section that your Heartland Bank credit faci lity represents a potentially important external source of liquidity for you. Pleas e tell us why you have not filed this credit facility as an exhibit to your annua l report on Form 10-K. Please note that if this credit facility is a material co ntract for purposes of Item 601(b)(10) of Regulation S-K, you should file the credit facility, incl uding all of its schedules and exhibits, with your next periodic re port or, if you wish, a current report on Form 8-K.

Exhibit 31.1 and Exhibit 31.2 10. We note that you have deleted the language “(the registrant’s f ourth fiscal quarter in the case of an annual report)” in each of the two certificatio ns required by Rule 13a-14(a) under the Securities Exchange Act of 1934, as amended. In future filings, please use the exact form of the certification specified in Item 601(b)(31) of Regulation S-K. Please refrain from deleting the aforementioned language or making other un-permitted changes to the fo rm of the certification. Generally, the only text within the form of the certificati on that may be changed is text that is contained within brackets in the form.

Form 10-Q for the quarterly period ended December 31, 2009 Note 1 - Basis of Presentation, Foreign Cu rrency and Change in Functional Currency, page 8 11. We note that you have adopted the U.S. do llar as your functiona l currency for all of your subsidiaries. Please provide us a specific and comprehensive discussion

Ms. Donna Felch The Female Health Company February 25, 2010 Page 4 regarding the changed facts and circ umstances, including how you considered each salient economic factor, in determin ing the U.S. dollar is the appropriate functional currency. Reference ASC 830-10-55-3.

Note 10 - FC1/FC2 Transition - Restructuring Costs, page 15

12. With a view toward future disclosure , please provide us a more specific and comprehensive explanation of how you determined the amount of the excess capacity costs and the amount of the dilapi dation and related expenses disclosed on page 17.

MD&A, Results of Operations, page 29

13. Please revise future annual and quarterly filings to quantify the impact of factors such as volume, pricing and raw material costs on your results, where practicable. For example, please disclose and discuss changes in volumes sold, average selling prices per unit and average cost of sales per unit for each period presented.

* * * * Please respond to these comments with in 10 business days, or tell us when you will provide us with a response. Please pr ovide us with a supplemental response letter that keys your responses to our comment s and provides any requested supplemental information. Detailed letters greatly facilitate our review. Please file your supplemental response on EDGAR as a correspondence file . Please understand that we may have additional comments after reviewin g your responses to our comments.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filings reviewed by the sta ff to be certain that they have provided all information investors require. Since the co mpany and its management are in possession of all facts relating to a company’s disclosure , they are responsible for the accuracy and adequacy of the disclosures they have made. In connection with responding to our comments, please provide, in writing, a statement from the company acknowledging that: • the company is responsible for the adequacy and accuracy of the disclosure in their 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 • 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.

Ms. Donna Felch The Female Health Company February 25, 2010 Page 5 In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Divi sion of Corporation Fi nance in our review of your filing or in response to our comments on your filing.

If you have any questions regarding co mments on the financial statements and related matters please direct them to Tric ia Armelin, Staff Account ant, at (202) 551-3747, or, in her absence, to the undersigned at (202) 551-3689. Please contact Dorine Miller, Financial Analyst, at (202) 551-3711or, in he r absence, Dieter Ki ng, Staff Attorney, at (202) 551-3338 with any other questions.

S i n c e r e l y , John Hartz Senior Assistant Chief Accountant

Show Raw Text
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-4631

       DIVISION OF
CORPORATION FINANCE

 Mail Stop 4631
February 25, 2010

Ms. Donna Felch The Female Health Company 515 N. State Street, Suite 2225 Chicago, IL
 RE: The Female Health Company
Form 10-K for the fiscal year ended September 30, 2009
  Filed December 17, 2009
File #1-13602

   Dear Ms. Felch:
We have reviewed your filings and have the following comments.  Where
indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to pr ovide us with supplemental information so
we may better understand your disclosure.  Af ter reviewing this information, we may or
may not raise additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure  requirements and to  enhance the overall
disclosure in your filing.  We look forward to  working with you in these respects.  We
welcome any questions you may have about our  comments or on any other aspect of our
review.  Feel free to call us at the telephone numbers listed at the end of this letter.
 Form 10-K for the fiscal year ended September 30, 2009

 Item 1. Business

Strategy, page 7
1. In future filings, please describe you r relationship with Hindustan Lifecare
Limited in greater detail.  Please publicl y file any agreements between you and
Hindustan Lifecare Limited that are material to your business.

Ms. Donna Felch
The Female Health Company February 25, 2010 Page 2    Government Regulation, page 10

2. In future filings, please expand the discu ssion in the second paragraph to explain
what you mean by, “FC2 received PMA as a Class III Medical Device.”  In doing
so, please explain what “PMA” means a nd explain the sign ificance of this
classification.
3. In future filings, please expand the disc ussion in the third paragraph to state
whether the company is in compliance w ith the conditions of the FDA’s approval
order relating to the company’s sales and distribution of the FC2 products.

Item 7. Management’s Discussion and Analys is of Financial Condition and Results of
Operations, page 18
Liquidity and Sources of Capital, page 24
4. We note your statement on page 25 that you believe your “current cash position is
adequate to fund operations . . . in the n ear future.”  In future filings, please
expand your liquidity discussion to addr ess liquidity on both a long-term and
short-term basis.  To the extent you can do so, when providing guidance about
your liquidity please use more precise pe riods (e.g., the next 12 months) rather
than terms like “in the near future,” whose meaning is less clear.  Please refer to
Item 303(a)(1) of Regulation S- K and Instruction 5 thereto.
5. We note that you have two revolving notes  with Heartland Bank.  Please revise
future filings to discuss the terms and conditions of any si gnificant covenants you
are subject to under these notes.  In a ddition, if you are subject to financial
covenants, please revise future annual a nd quarterly filings to present, for the
most significant and restrictive covenants,  actual ratios and other actual amounts
versus the minimum/maximum ratios/amounts required at each reporting date.  Such a presentation may allow investor s to more easily assess and understand
your current status and future ability to meet your covenants.  See Sections I.D
and IV.C of the SEC Inte rpretive Release No. 33-8350

Note 1. Nature of Business and Signif icant Accounting Policies, page F-7
Accounts receivable and concentra tion of credit risk, page F-7
6. Please revise future filings to disclose the percentages of sales to significant
customers for each period presented.  Re ference Item 101 of Regulation S-K and
ASC 280-10-50-42.

Ms. Donna Felch
The Female Health Company February 25, 2010 Page 3   Note 6 - Income Taxes, page F-14

7. With a view toward future disclosure, please provide us a more specific and
comprehensive explanation of how you de termined changes in your tax valuation
allowance during each period presented.  Se parately address your ability to utilize
U.S. and foreign carry-forwards.

Note 13 - Restructuri ng Costs, page F-23
8. With a view toward future disclosure , please provide us a more specific and
comprehensive discussion of the nature of your restructuring costs.   In this regard,
please clarify your “redundancy” and “o ther expenses”.  Reference ASC 420-10-
50.  Also, please explain to us how you dete rmined the appropriate time period to
accrue the restructuring costs that you  recorded in FY 2009 and FY 2010.

Item 15. Exhibits and Financia l Statement Schedules, page 43
9. We note from your disclosure in the Management’s Discussion and Analysis
section that your Heartland Bank credit faci lity represents a potentially important
external source of liquidity for you.  Pleas e tell us why you have not filed this
credit facility as an exhibit to your annua l report on Form 10-K.  Please note that
if this credit facility is a material co ntract for purposes of Item 601(b)(10) of
Regulation S-K, you should file  the credit facility, incl uding all of its schedules
and exhibits, with your next periodic re port or, if you wish, a current report on
Form 8-K.

Exhibit 31.1 and Exhibit 31.2
10. We note that you have deleted the language “(the registrant’s f ourth fiscal quarter
in the case of an annual report)” in each of the two certificatio ns required by Rule
13a-14(a) under the Securities Exchange  Act of 1934, as amended.  In future
filings, please use the exact form of the certification specified in Item 601(b)(31)
of Regulation S-K.  Please refrain from deleting the aforementioned language or
making other un-permitted changes to the fo rm of the certification.  Generally, the
only text within the form of the certificati on that may be changed is text that is
contained within brackets in the form.

Form 10-Q for the quarterly period ended December 31, 2009
 Note 1 - Basis of Presentation, Foreign Cu rrency and Change in Functional Currency,
page 8
11. We note that you have adopted the U.S. do llar as your functiona l currency for all
of your subsidiaries.  Please provide us  a specific and comprehensive discussion

Ms. Donna Felch
The Female Health Company February 25, 2010 Page 4
regarding the changed facts and circ umstances, including how you considered
each salient economic factor, in determin ing the U.S. dollar is the appropriate
functional currency.  Reference ASC 830-10-55-3.

Note 10 - FC1/FC2 Transition - Restructuring Costs, page 15

12. With a view toward future disclosure , please provide us a more specific and
comprehensive explanation of how you determined the amount of the excess capacity costs and the amount of the dilapi dation and related expenses disclosed
on page 17.

MD&A, Results of Operations, page 29

13. Please revise future annual and quarterly filings to quantify the impact of factors
such as volume, pricing and raw material costs on your results, where practicable.
For example, please disclose and discuss changes in volumes sold, average selling
prices per unit and average cost of sales per unit for each period presented.

*    *    *    *
   Please respond to these comments with in 10 business days, or tell us when you
will provide us with a response.  Please pr ovide us with a supplemental response letter
that keys your responses to our comment s and provides any requested supplemental
information.  Detailed letters greatly facilitate our review.  Please file your supplemental
response on EDGAR as a correspondence file .  Please understand that we may have
additional comments after reviewin g your responses to our comments.

 We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filings reviewed by the sta ff to be certain that they have provided all
information investors require.  Since the co mpany and its management are in possession
of all facts relating to a company’s disclosure , they are responsible for the accuracy and
adequacy of the disclosures they have made.     In connection with responding to our comments, please provide, in writing, a
statement from the company acknowledging that:
• the company is responsible for the adequacy  and accuracy of the disclosure in their
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
• 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.

Ms. Donna Felch
The Female Health Company February 25, 2010 Page 5
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.

If you have any questions regarding co mments on the financial statements and
related matters please direct them to Tric ia Armelin, Staff Account ant, at (202) 551-3747,
or, in her absence, to the undersigned at (202) 551-3689.  Please contact Dorine Miller,
Financial Analyst, at (202) 551-3711or, in he r absence, Dieter Ki ng, Staff Attorney, at
(202) 551-3338 with any other questions.

         S i n c e r e l y ,             John Hartz
       Senior Assistant Chief Accountant