February
11, 2008
SENT
VIA
EDGAR
Mr.
John
Cash
Accounting
Branch Chief
United
States Securities and Exchange Commission
Division
of Corporation Finance
Washington,
D.C. 20549
Re:
The
Female Health Company Form 10-KSB
for the year ended September 30, 2007
File
No. 1-13602
Dear
Mr.
Cash:
The
following are the responses of The Female Health Company (the "Company") to
the
comments in the letter of the staff of the Securities and Exchange Commission
dated January 30, 2008 relating to the Company's Form 10-KSB for the year
ended September 30, 2007. For reference purposes, the text of
the staff's comment letter has been reproduced below with responses below for
each numbered paragraph.
Form
10-KSB for the Year
Ended September 30, 2007
General
Comment
No.
1
It
appears that your public float may have exceeded $25 million in the years ended
September 30, 2007, 2006 and 2005. Please clarify for us how you determined
that you qualify as a small business issuer. Reference Item 10
of Regulation S-B.
Response
to Comment No.
1
With
respect to the public float limit, Item 10(a)(2)(iii) of
Regulation S-B provides that once a small business issuer becomes a
reporting company it will remain a small business issuer until it exceeds the
public float limit at the end of two consecutive years. The public
float limit is tested by use of a price at which the Company's stock was last
sold, or the average of the bid and asked prices of such stock, on a date within
60 days prior to the end of the Company's fiscal year end.
As
of
September 30, 2006, there were 24,208,391 shares of the Company's $0.01 par
value common stock (the "Common Stock") outstanding, the only class of common
equity of the Company. Directors and executive officers of the
Company (who are all affiliates of the Company) collectively held 7,602,788
shares of Common Stock as of September 30, 2006. As a result, the
number of shares of Common Stock held by non-affiliates was
16,605,603. On September 25, 2006, a date within 60 days of the
Company's fiscal year end of September 30, 2006, the Common Stock closed at
$1.20 per share on the OTC Bulletin Board. At that price, the
Company's public float was $19,926,724 (16,605,603 shares x $1.20 =
$19,926,724). Because that number is less than $25 million, the
Company was under the public float limit for its fiscal year ended
September 30, 2006, and because ending small business issuer status
requires that an issuer exceed the public float limit for two consecutive years,
the Company was also a small business issuer for its fiscal years ended
September 30, 2007 and September 30, 2005.
Item
1. Description of
Business, page 5
Product,
page
5
Comment
No.
2.
Please
revise future filings to disclose and discuss the process and expected timing
for FDA approval of FC2.
Response
to Comment No.
2:
The
disclosure in the Company’s Form 10-QSB for the quarter ended
December 31, 2007 will be expanded to read as follows:
The
FC2
pre-market approval application (PMA) submitted by the Company on January 8,
2008, was accepted for FDA review on January 28, 2008. That
acceptance marks the beginning of the FDA review process, which generally can
take up to 180 active review days. During this process, the FDA may
ask questions regarding the submission. The time spent on answering
such questions is not counted as review process time. Following the
FDA review, the submission’s merits will be reviewed and discussed by FDA’s
OB-GYN Device Advisory Panel. The final step to approval is
negotiation and approval of the product’s labeling. The entire
process may typically take up to 360 days.
Item
6. MD&A – Liquidity
and Sources of Capital, page 20
Comment
3
With
a view towards future disclosure, please explain to us why your accounts
receivable balance significantly increased and help us understand why days
outstanding are so significant in light of the fact that your disclosed payments
terms are a net 30 day basis.
Response
to Comment No.
3:
Historically,
the Company’s “standard” credit terms to its largest customer class has been 30
days net. However, as the Company business with distribution partners
expanded, it was necessary to offer competitive credit terms typical for that
customer class. Such terms vary from 60 to 90 days net, depending on
what is customary in the country where the distributor does
business. Also, as is typical in the Company's business, the Company
occasionally offers extended credit terms as a sales promotion. The
increased sales to distributors and the occasional credit extension have
increased days outstanding for sales in recent periods. An analysis
of the past five quarters reveals that days’ sales outstanding average is about
60 days.
To
understand the accounts receivable balance at year end, it is necessary to
know
the Company’s production and sales pattern. A typical quarter falls
like this: In the first half of each quarter, the Company's UK
subsidiary produces goods to be sold by its North American parent. As
a result, a significant portion of the sales in the first half of the quarter
are inter-company transactions which have no impact on accounts receivable
as it
eliminates in consolidation. These inter-company sales arrive in the
US from about mid-quarter and onward. So the US parent’s sales occur
primarily in the second half of the quarter, a function of when its inventory
arrives. Production of inter-company sales in months one and two also reduces
the UK subsidiary’s third party sales in the first half of the
quarter. Thus, the Company’s pattern of production and sales tends to
cause accounts receivable to spike near the quarter end.
At
September 30, 2007, the accounts receivable balance of $6.1 million
represented approximately 74 days’ sales outstanding. This was due to
both the Company’s typical production and sales pattern and the inclusion of a
$1 million invoice with extended terms (120 days).
In
future
filings, the Company will expand the credit terms disclosure to describe the
Company's terms and reflect the current average days’ sales
outstanding.
Note
1. Nature of Business
and Significant Accounting Policies, page F-7
Deferred
Grant Income, page
F-9
Comment
No.
4:
Please
provide us a more comprehensive discussion of the nature of the project for
which you received grant money from the British Linkage Challenge
Fund. In this regard, please also more fully describe how you
determined that the contributions should be recognized as income.
Response
to Comment No.
4:
The
Company receives grant monies from the British Linkage Challenge Fund (the
"BLCF"). This fund was set up by the UK Department for International
Development and is a cost and risk sharing grant scheme to develop partnerships
between businesses nationally and internationally and to carry out innovative
pilot projects. The grants are provided on the basis of a 1:1 funding by the
BLCF and the companies involved. The BLCF's goal is to improve access to
sustainable livelihood opportunities for poor people by improving the
competitiveness and ability of business to access markets. This is done through
linkages that exchange technology, skill, information and market access. The
BLCF's expected outcomes are productive inter-firm linkages among firms of
all
sizes and all activity, involved in export or domestic markets, services as
well
as processed goods.
The
project for which the Company receives this grant relates to the development
of
a linkage with Hindustan Latex Limited, in India, to manufacture the
female condom in India and develop the market for the product in that
country.
The
grant
received is split between the Company and Hindustan Latex Limited pro-rata
to
their respective expenditure on the project.
The
Company recognized that there are no U.S. accounting pronouncements that
specifically address how to account for government grants. The
Company utilized the general precepts of U.S. GAAP and the principles of
matching and conservatism to determine how to account for the grant monies
received. The Company also utilized the guidance of International
Accounting Standard No. 20 – Accounting for Government Grants and Disclosure of
Government Assistance to further support the Company's accounting treatment
of
the grant received. The Company allocates its share of the grant
monies to capital and expense pro-rata to the respective cost allocated to
the
project. Grant proceeds for expenses are credited to income in the quarter
incurred. Grant proceeds for capital expenditure are deferred and released
to income in line with the depreciation of the relevant assets.
Note
6. Income Taxes, page
F-12
Comment
No.
5
Please
revise future filings to disclose and discuss how you determined the amount
of
tax valuation allowance that you released and how you will assess the remaining
allowance in future periods.
Response
to Comment No.
5:
We
account for income taxes using the liability method, which requires the
recognition of deferred tax assets or liabilities for the tax-affected temporary
differences between the financial reporting and tax bases of our assets and
liabilities, and for net operating loss and tax credit
carryforwards.
During
fiscal year 2007, we recorded an income tax benefit of $825,000. This benefit
consisted of an $825,000 reduction in the valuation allowance related to a
portion of our deferred tax assets that will more likely than not be realized,
based on future projected taxable income. In evaluating our ability to realize
our deferred tax assets we consider all available positive and negative evidence
including our past operating results and our forecast of future taxable income.
In determining future taxable income, we make assumptions to forecast U.S.
federal, U.S. state, and international operating income, the reversal of
temporary differences, and the implementation of any feasible and prudent tax
planning strategies. These assumptions require significant judgment regarding
the forecasts of future taxable income, and are consistent with the forecasts
used to manage our business. We intend to maintain the remaining valuation
allowance until sufficient further positive evidence exists to support further
reversals of the valuation allowance. Our income tax expense recorded in the
future will be reduced to the extent of offsetting decreases in our valuation
allowance. We will expand the discussion of the determination of our
tax valuation allowance in future filings.
The
Company acknowledges that (i) it is responsible for the adequacy and accuracy
of
the disclosure in its filings; (ii) 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 (iii) it 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.
Please
contact me at (312) 595-9742 if you have any questions on any of the responses
to your comments.
Best
regards,
The
Female Health Company
/s/
Donna
Felch
Donna
Felch
Vice
President and Chief Financial Officer
5