U.S.
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10-QSB
(MARK
ONE)
[X]
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the quarterly period ended June 30,
2008
[ ]
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT
|
For
the transition period from
__________ to ____________
Commission
File Number 1-13602
THE
FEMALE HEALTH COMPANY
|
(Exact
Name of Small Business Issuer as Specified in Its
Charter)
|
Wisconsin
|
|
39-1144397
|
(State
or Other Jurisdiction of
|
|
(I.R.S.
Employer Identification No.)
|
Incorporation
or Organization)
|
|
|
515
North State Street, Suite 2225, Chicago, IL
|
|
60654
|
(Address
of Principal Executive Offices)
|
|
(Zip
Code)
|
312-595-9123
|
(Issuer's
Telephone Number, Including Area
Code)
|
Not
applicable
|
(Former
Name, Former Address and Former Fiscal Year,
|
If
Changed Since Last Report)
|
|
Check
whether the issuer: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Exchange Act during the past 12 months (or for
such shorter period that the issuer was required to file such reports) and
(2)
has been subject to such filing requirements for the past
90 days. YES [X] NO
[ ]
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b2
of the Exchange Act). YES [
] NO
[X]
State
the
number of shares outstanding of each of the issuer's classes of common equity,
as of the latest practical date:
Common
Stock, $.01 Par Value – 26,957,908 shares outstanding as of August 6,
2008
Transitional
Small Business Disclosure Format (check one):
YES [
] NO
[X]
FORM
10-QSB
THE
FEMALE HEALTH COMPANY AND SUBSIDIARIES
INDEX
PART
I.
|
FINANCIAL
INFORMATION AND MANAGEMENT'S
|
|
PAGE
|
|
|
Cautionary
Statement Regarding Forward Looking Statements
|
3
|
|
|
Unaudited
Condensed Consolidated Balance Sheets -
June
30, 2008 and September 30, 2007
|
4
|
|
|
Unaudited
Condensed Consolidated Statements
of
Income -
Three
Months
Ended June 30, 2008 and
June 30,
2007
Nine
months
Ended June 30, 2008 and
June 30,
2007
|
5
6
|
|
|
Unaudited
Condensed ConsolidatedStatements
of
Cash Flows -
Nine
months
Ended June 30, 2008 and
June 30,
2007
|
7
|
|
|
Notes
to Unaudited Condensed Consolidated
Financial Statements
|
8
|
|
|
Management's
Discussion and Analysis
|
17
|
|
|
Controls
and Procedures
|
31
|
PART
II.
|
OTHER
INFORMATION
|
Items
1 – 5
|
32
|
|
|
Exhibits
|
32
|
CAUTIONARY
STATEMENT REGARDING
FORWARD
LOOKING STATEMENTS
Certain
statements included in this quarterly report on Form 10-QSB which are not
statements of historical fact are intended to be, and are hereby identified
as
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. The Company cautions readers that forward-looking
statements involve known and unknown risks, uncertainties and other factors
that
may cause the actual results, performance or achievements of the Company to
be
materially different from any future results, performance or achievement
expressed or implied by such forward-looking statements. Such factors include,
among others, the following: the Company's inability to secure adequate capital
to fund working capital requirements and advertising and promotional
expenditures; factors related to increased competition from existing and new
competitors including new product introduction, price reduction and increased
spending on marketing; limitations on the Company's opportunities to enter
into
and/or renew agreements with international partners, the failure of the Company
or its partners to successfully market, sell and deliver its product in
international markets, and risks inherent in doing business on an international
level, such as laws governing medical devices that differ from those in the
U.S., unexpected changes in the regulatory requirements, political risks, export
restrictions, tariffs and other trade barriers and fluctuations in currency
exchange rates; the disruption of production at the Company's manufacturing
facilities due to raw material shortages, labor shortages and/or physical damage
to the Company's facilities; the Company's inability to manage its growth and
to
adapt its administrative, operational and financial control systems to the
needs
of the expanded entity and the failure of management to anticipate, respond
to
and manage changing business conditions; the loss of the services of executive
officers and other key employees and the Company's continued ability to attract
and retain highly-skilled and qualified personnel; the costs and other effects
of litigation, governmental investigations, legal and administrative cases
and
proceedings, settlements and investigations; and developments or assertions
by
or against the Company relating to intellectual property rights.
THE
FEMALE HEALTH COMPANY AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED BALANCE SHEETS
ASSETS
|
|
June
30, 2008
|
|
|
September
30, 2007
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash
|
|
$ |
1,586,842 |
|
|
$ |
799,421 |
|
Restricted
cash
|
|
|
236,887 |
|
|
|
86,435 |
|
Accounts
receivable, net
|
|
|
5,964,736 |
|
|
|
6,080,153 |
|
Inventories,
net
|
|
|
2,161,161 |
|
|
|
1,372,582 |
|
Prepaid
expenses and other current assets
|
|
|
415,311 |
|
|
|
399,536 |
|
Deferred
income taxes
|
|
|
1,369,000 |
|
|
|
825,000 |
|
TOTAL
CURRENT ASSETS
|
|
|
11,733,937 |
|
|
|
9,563,127 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Assets
|
|
|
248,753 |
|
|
|
251,536 |
|
|
|
|
|
|
|
|
|
|
EQUIPMENT,
FURNITURE AND FIXTURES
|
|
|
|
|
|
|
|
|
Equipment
not yet in service
|
|
|
- |
|
|
|
444,275 |
|
Equipment,
furniture and fixtures
|
|
|
6,515,163 |
|
|
|
5,967,082 |
|
Total
equipment, furniture and fixtures
|
|
|
6,515,163 |
|
|
|
6,411,357 |
|
Less
accumulated depreciation and amortization
|
|
|
5,011,944 |
|
|
|
5,032,472 |
|
|
|
|
1,503,219 |
|
|
|
1,378,885 |
|
TOTAL
ASSETS
|
|
$ |
13,485,909 |
|
|
$ |
11,193,548 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
1,073,434 |
|
|
$ |
806,134 |
|
Accrued
expenses and other current liabilities
|
|
|
2,281,822 |
|
|
|
1,555,346 |
|
Preferred
dividends payable
|
|
|
27,654 |
|
|
|
53,025 |
|
TOTAL
CURRENT LIABILITIES
|
|
|
3,382,910 |
|
|
|
2,414,505 |
|
|
|
|
|
|
|
|
|
|
Deferred
gain on sale of facility
|
|
|
963,862 |
|
|
|
1,074,339 |
|
Deferred
grant income
|
|
|
235,268 |
|
|
|
257,245 |
|
TOTAL
LIABILITIES
|
|
|
4,582,040 |
|
|
|
3,746,089 |
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS’
EQUITY:
|
|
|
|
|
|
|
|
|
Convertible
preferred stock, Class A Series 1
|
|
|
- |
|
|
|
560 |
|
Convertible
preferred stock, Class A Series 3
|
|
|
3,234 |
|
|
|
4,734 |
|
Convertible
preferred stock, Class B
|
|
|
- |
|
|
|
- |
|
Common
stock
|
|
|
269,169 |
|
|
|
264,379 |
|
Additional
paid-in-capital
|
|
|
65,233,626 |
|
|
|
64,954,610 |
|
Accumulated
other comprehensive income
|
|
|
865,056 |
|
|
|
1,051,156 |
|
Accumulated
deficit
|
|
|
(55,939,262 |
) |
|
|
(58,428,233 |
) |
Treasury
stock, at cost
|
|
|
(1,527,954 |
) |
|
|
(399,747 |
)
|
TOTAL
STOCKHOLDERS’ EQUITY
|
|
|
8,903,869 |
|
|
|
7,447,459 |
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
$ |
13,485,909 |
|
|
$ |
11,193,548 |
|
See
notes
to unaudited condensed consolidated financial statements.
THE
FEMALE HEALTH COMPANY AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
|
|
Three
Months Ended
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$ |
5,657,418 |
|
|
$ |
4,623,190 |
|
Royalty
income
|
|
|
707 |
|
|
|
- |
|
Net
revenues
|
|
|
5,658,125 |
|
|
|
4,623,190 |
|
|
|
|
|
|
|
|
|
|
Cost
of sales
|
|
|
3,480,400 |
|
|
|
2,810,291 |
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
|
|
2,177,725 |
|
|
|
1,812,899 |
|
|
|
|
|
|
|
|
|
|
Advertising
and promotion
|
|
|
50,969 |
|
|
|
38,056 |
|
Selling,
general and administrative
|
|
|
1,715,515 |
|
|
|
1,371,339 |
|
Research
and development
|
|
|
14,865 |
|
|
|
32,927 |
|
|
|
|
|
|
|
|
|
|
Total
operating expenses
|
|
|
1,781,349 |
|
|
|
1,442,322 |
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
|
396,376 |
|
|
|
370,577 |
|
|
|
|
|
|
|
|
|
|
Interest,
net and other income
|
|
|
(13,964 |
) |
|
|
(10,804 |
) |
Foreign
currency transaction loss
|
|
|
36,680 |
|
|
|
23,905 |
|
Income
before income taxes
|
|
|
373,660 |
|
|
|
357,476 |
|
|
|
|
|
|
|
|
|
|
Income
tax benefit
|
|
|
(167,000 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
|
540,660 |
|
|
|
357,476 |
|
|
|
|
|
|
|
|
|
|
Preferred
dividends, Class A, Series 1
|
|
|
2,782 |
|
|
|
2,792 |
|
Preferred
dividends, Class A, Series 3
|
|
|
28,811 |
|
|
|
37,410 |
|
|
|
|
|
|
|
|
|
|
Net
income attributable to common stockholders
|
|
$ |
509,067 |
|
|
$ |
317,274 |
|
|
|
|
|
|
|
|
|
|
Net
income per basic common share outstanding
|
|
$ |
0.02 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
Basic
weighted average common shares outstanding
|
|
|
26,144,583 |
|
|
|
25,902,539 |
|
|
|
|
|
|
|
|
|
|
Net
income per diluted common share outstanding
|
|
$ |
0.02 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
Diluted
weighted average common shares outstanding
|
|
|
28,117,178 |
|
|
|
28,753,523 |
|
See
notes
to unaudited condensed consolidated financial statements.
THE
FEMALE HEALTH COMPANY AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
|
|
Nine
months Ended
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$ |
17,788,503 |
|
|
$ |
14,145,663 |
|
Royalty
income
|
|
|
5,650 |
|
|
|
- |
|
Net
revenues
|
|
|
17,794,153 |
|
|
|
14,145,663 |
|
|
|
|
|
|
|
|
|
|
Cost
of sales
|
|
|
10,577,665 |
|
|
|
9,020,269 |
|
|
|
|
|
|
|
|
|
|
Gross
profit
|
|
|
7,216,488 |
|
|
|
5,125,394 |
|
|
|
|
|
|
|
|
|
|
Advertising
and promotion
|
|
|
161,345 |
|
|
|
131,020 |
|
Selling,
general and administrative
|
|
|
4,899,747 |
|
|
|
4,336,715 |
|
Research
and development
|
|
|
202,241 |
|
|
|
156,668 |
|
|
|
|
|
|
|
|
|
|
Total
operating expenses
|
|
|
5,263,333 |
|
|
|
4,624,403 |
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
|
1,953,155 |
|
|
|
500,991 |
|
|
|
|
|
|
|
|
|
|
Interest,
net and other income
|
|
|
(30,629 |
) |
|
|
(35,220 |
) |
Foreign
currency transaction (gain) loss
|
|
|
(73,625 |
) |
|
|
7,908 |
|
Income
before income taxes
|
|
|
2,057,409 |
|
|
|
528,303 |
|
|
|
|
|
|
|
|
|
|
Income
tax benefit
|
|
|
(544,000 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
|
2,601,409 |
|
|
|
528,303 |
|
|
|
|
|
|
|
|
|
|
Preferred
dividends, Class A, Series 1
|
|
|
8,397 |
|
|
|
8,377 |
|
Preferred
dividends, Class A, Series 3
|
|
|
104,041 |
|
|
|
112,228 |
|
|
|
|
|
|
|
|
|
|
Net
income attributable to common stockholders
|
|
$ |
2,488,971 |
|
|
$ |
407,698 |
|
|
|
|
|
|
|
|
|
|
Net
income per basic common share outstanding
|
|
$ |
0.10 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
Basic
weighted average common shares outstanding
|
|
|
26,117,888 |
|
|
|
24,609,431 |
|
|
|
|
|
|
|
|
|
|
Net
income per diluted common share outstanding
|
|
$ |
0.09 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
Diluted
weighted average common shares outstanding
|
|
|
28,101,867 |
|
|
|
26,853,041 |
|
See
notes
to unaudited condensed consolidated financial statements.
THE
FEMALE HEALTH COMPANY AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
Nine
months Ended
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
OPERATIONS
|
|
|
|
|
|
|
Net
income
|
|
$ |
2,601,409 |
|
|
$ |
528,303 |
|
Adjustment
for noncash items:
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
143,482 |
|
|
|
100,949 |
|
Amortization
of deferred gain on sale/leaseback
|
|
|
(85,620 |
) |
|
|
(85,032 |
) |
Amortization
of deferred income from grant - BLCF
|
|
|
(15,995 |
) |
|
|
- |
|
Interest
added to certificate of deposit
|
|
|
(1,925 |
) |
|
|
(1,832 |
) |
Amortization
of unearned consulting fees
|
|
|
57,000 |
|
|
|
175,000 |
|
Employee
stock compensation
|
|
|
225,766 |
|
|
|
509,851 |
|
Deferred
income taxes
|
|
|
(544,000 |
) |
|
|
- |
|
Loss
on disposal of fixed assets
|
|
|
6,380 |
|
|
|
- |
|
Changes
in operating assets and liabilities
|
|
|
223,008 |
|
|
|
(486,064 |
) |
Net
cash provided by operating activities
|
|
|
2,609,505 |
|
|
|
741,175 |
|
|
|
|
|
|
|
|
|
|
INVESTING
ACTIVITIES
|
|
|
|
|
|
|
|
|
(Increase)
decrease in restricted cash
|
|
|
(150,452 |
) |
|
|
168,481 |
|
Proceeds
from disposal of fixed assets
|
|
|
14,062 |
|
|
|
- |
|
Capital
expenditures
|
|
|
(344,056 |
) |
|
|
(799,677 |
) |
Net
cash used in investing activities
|
|
|
(480,446 |
) |
|
|
(631,196 |
) |
|
|
|
|
|
|
|
|
|
FINANCING
ACTIVITIES
|
|
|
|
|
|
|
|
|
Proceeds
from exercise of stock options
|
|
|
196,250 |
|
|
|
96,600 |
|
Proceeds
from exercise of warrants
|
|
|
422,500 |
|
|
|
- |
|
Purchases
of common stock for treasury shares
|
|
|
(1,128,206 |
) |
|
|
(241,034 |
) |
Redemption
and repurchase of preferred stock
|
|
|
(580,500 |
) |
|
|
- |
|
Dividends
paid on preferred stock
|
|
|
(137,822 |
) |
|
|
(7,200 |
) |
Net
cash used in financing activities
|
|
|
(1,227,778 |
) |
|
|
(151,634 |
) |
|
|
|
|
|
|
|
|
|
Effect
of exchange rate changes on cash
|
|
|
(113,860 |
) |
|
|
69,777 |
|
|
|
|
|
|
|
|
|
|
Net
increase in cash
|
|
|
787,421 |
|
|
|
28,122 |
|
Cash
at beginning of period
|
|
|
799,421 |
|
|
|
1,827,393 |
|
|
|
|
|
|
|
|
|
|
CASH
AT END OF PERIOD
|
|
$ |
1,586,842 |
|
|
$ |
1,855,515 |
|
|
|
|
|
|
|
|
|
|
Schedule
of noncash financing and investing activities:
|
|
|
|
|
|
|
|
|
Common
stock issued for payment of preferred stock dividends
|
|
$ |
- |
|
|
$ |
112,227 |
|
Reduction
of accrued expense upon issuance of shares
|
|
|
51,203 |
|
|
|
142,999 |
|
Preferred
dividends declared
|
|
|
27,654 |
|
|
|
8,377 |
|
Liability
for preferred stock redemption
|
|
|
15,000 |
|
|
|
- |
|
See
notes
to unaudited condensed consolidated financial statements.
THE
FEMALE HEALTH COMPANY AND SUBSIDIARIES
NOTES
TO
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 -
Basis of
Presentation
The
accompanying financial statements are unaudited but in the opinion of management
contain all the adjustments (consisting of those of a normal recurring nature)
considered necessary to present fairly the financial position and the results
of
operations and cash flow for the periods presented in conformity with generally
accepted accounting principles for interim financial information and the
instructions to Form 10-QSB and Article 10 of Regulation S-X. Accordingly,
they do not include all of the information and footnotes required by United
States generally accepted accounting principles for complete financial
statements.
Operating
results for the three months and nine months ended June 30, 2008 are not
necessarily indicative of the results that may be expected for the fiscal year
ending September 30, 2008. For further information, refer to the consolidated
financial statements and footnotes thereto included in the Company's annual
report on Form 10-KSB for the fiscal year ended September 30,
2007.
Principles
of consolidation
and nature of operations:
The
consolidated financial statements include the accounts of the Company and its
wholly owned subsidiary, The Female Health Company – UK, and its wholly owned
subsidiary, The Female Health Company - UK, plc as well as The Female Health
Company (M) SDN. BHD, a wholly owned subsidiary of The Female Health Company-UK.
All significant intercompany transactions and accounts have been eliminated
in
consolidation. The Female Health Company ("FHC" or the "Company") is currently
engaged in the marketing, manufacture and distribution of a consumer health
care
product, the female condom. The original female condom is known as
the “FC Female Condom” in the U.S., and "femidom" or "femy" outside the U.S; the
second generation product is known as FC2 throughout the world. The
Female Health Company - UK, is the holding company of The Female Health Company
- UK, plc, which operates a 40,000 sq. ft. leased manufacturing facility located
in London, England. The Female Health Company (M) SDN.BHD leases a 16,000 sq.
ft. manufacturing facility located in Selangor D.E., Malaysia.
The
product is currently sold or available in either or both commercial (private
sector) and public sector markets in 116 countries. The product is marketed
in
15 countries by various country-specific commercial partners. The Company's
standard credit terms vary from 30 to 90 days, depending on the class of trade
and customary terms within a territory, so accounts receivable is affected
by
the mix of purchasers within the quarter. As is typical in the
Company's business, extended credit terms may occasionally be offered as a
sales
promotion. For the past twelve months, the Company's average days
sales outstanding has averaged approximately 94 days. Over the past
five years, the Company’s bad debt expense has been less than .01% of
sales.
Under
an
interim agreement, the Company authorized Hindustan Latex Limited ("HLL") to
produce FC2 for sale in India in exchange for a royalty per unit. The
companies are in the process of negotiating a permanent agreement.
Restricted
cash:
Restricted
cash relates to security provided to one of the Company’s U.K. banks for
performance bonds issued in favor of customers. Such security has been extended
infrequently and only on occasions where it has been a contract term expressly
stipulated as an absolute requirement by the funds provider. The expiration
of
the bond is defined by the completion of the event such as, but not limited
to,
delivery of goods or at a period of time after product has been
distributed.
Reclassification:
Certain
items in the financial statements for the three and nine months ended June
30,
2007 have been reclassified to be consistent with the presentation shown for
the
three and nine months ended June 30, 2008
NOTE
2 -
Earnings per
Share
Basic
EPS
is computed by dividing income attributable to common stockholders by the
weighted average number of common shares outstanding for the period. In the
diluted earnings per share calculation, the numerator is the sum of net income
attributable to common stockholders and preferred dividends. Diluted EPS is
computed giving effect to all dilutive potential common shares that were
outstanding during the period. Dilutive potential common shares
consist of the incremental common shares issuable upon conversion of convertible
preferred shares and the exercise of stock options and warrants and unvested
shares granted to employees.
|
|
Three
Months Ended
June
30,
|
|
|
Nine
months Ended
June
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding
–
basic
|
|
|
26,144,583 |
|
|
|
25,902,539 |
|
|
|
26,117,888 |
|
|
|
24,609,431 |
|
Net
effect of dilutive securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
|
|
|
837,587 |
|
|
|
1,249,258 |
|
|
|
845,130 |
|
|
|
820,224 |
|
Warrants
|
|
|
744,131 |
|
|
|
854,349 |
|
|
|
747,972 |
|
|
|
676,009 |
|
Convertible
preferred stock
|
|
|
323,377 |
|
|
|
529,377 |
|
|
|
323,377 |
|
|
|
529,377 |
|
Unvested
restricted shares
|
|
|
67,500 |
|
|
|
218,000 |
|
|
|
67,500 |
|
|
|
218,000 |
|
Total
net effect of dilutive securities
|
|
|
1,972,595 |
|
|
|
2,850,984 |
|
|
|
1,983,979 |
|
|
|
2,243,610 |
|
Weighted
average common shares
outstanding
–
diluted
|
|
|
28,117,178 |
|
|
|
28,753,523 |
|
|
|
28,101,867 |
|
|
|
26,853,041 |
|
Income
per common share – basic
|
|
$ |
0.02 |
|
|
$ |
0.01 |
|
|
$ |
0.10 |
|
|
$ |
0.02 |
|
Income
per common share – diluted
|
|
$ |
0.02 |
|
|
$ |
0.01 |
|
|
$ |
0.09 |
|
|
$ |
0.02 |
|
Warrants
to purchase approximately
50,000 shares of common stock at an exercise price of $2.65 that were
outstanding during the three and nine months ended June 30, 2008, were not
included in the computation of diluted net income per share because the effect
would have been anti-dilutive. These
warrants expire in July 2009.
Warrants to purchase approximately 450,000 shares of common stock at exercise
prices ranging from $2.25 to $3.10 per share that were outstanding during the
three and nine month
periods ended June 30, 2007, were not included in the computation of diluted
net
income per share because their effect was anti-dilutive. In March 2008, 400,000
of these warrants expired. The remaining 50,000 will expire in July
2009.
NOTE
3 -
Comprehensive
Income
Total
comprehensive income was $566,889 for the three months ended June 30, 2008
and
$479,861 for the three months ended June 30, 2007. Total comprehensive income
was $2,415,309 for the nine months ended June 30, 2008 and $871,533 for the
nine
months ended June 30, 2007.
NOTE
4 -
Inventories
The
components of inventory consist of the following:
|
|
June
30,
2008
|
|
|
September
30,
2007
|
|
Raw
material and work in process
|
|
$ |
1,369,125 |
|
|
$ |
1,082,083 |
|
Finished
goods
|
|
|
838,036 |
|
|
|
358,499 |
|
Inventory,
gross
|
|
|
2,207,161 |
|
|
|
1,440,582 |
|
Less:
inventory reserves
|
|
|
(46,000 |
) |
|
|
(68,000 |
) |
Inventory,
net
|
|
$ |
2,161,161 |
|
|
$ |
1,372,582 |
|
NOTE
5 –
Share-Based
Compensation
Stock
Option
Plans
Under
the
Company’s previous share based long-term incentive compensation plan, the 1997
Stock Option Plan, the Company granted non-qualified stock options to
employees. There are no shares available for grant under the plan
which expired on December 31, 2006. Options issued under that plan
expire in 10 years and generally vested 1/36 per month, with full vesting after
three years.
In
March
2008, the Company’s shareholders approved the 2008 Stock Incentive Plan which
will be utilized to provide equity opportunities and performance –based
incentives to attract, retain and motivate those persons who make (or are
expected to make) important contributions to the Company. A total of
2,000,000 shares are available for issuance under the plan. As of
June 30, 2008, 20,000 shares had been issued under the plan.
The
Company recognized share-based compensation expense for stock options of
approximately $12,000 and $45,000 in selling, general and administrative
expenses in the statement of operations for the three and nine months ended
June
30, 2008, respectively, and $28,000 and $90,000 for the three and nine months
ended June 30, 2007, respectively.
The
Company granted 180,000 stock options during the first nine months of fiscal
2007. The Company did not grant any options during the first nine months of
fiscal 2008. The table below outlines the weighted average assumptions for
options granted during the nine months ended June 30, 2007:
|
|
Nine
months Ended
June
30, 2007
|
|
Weighted
Average Assumptions:
|
|
|
|
Expected
volatility
|
|
|
61.2 |
% |
Expected
dividend yield
|
|
|
0 |
% |
Risk-free
interest rate
|
|
|
5.10 |
% |
Expected
term (in years)
|
|
|
10.0 |
|
Fair
value of options granted
|
|
$ |
0.95 |
|
The
following table summarizes the Company’s option activity during the nine months
ended June 30, 2008:
Option
Activity:
|
Number
of Shares
|
|
Weighted
Average
Exercise
Price
|
Outstanding
at September 30, 2007
|
2,745,980
|
|
$ 1.37
|
Granted
|
0
|
|
-
|
Exercised
|
136,000
|
|
1.44
|
Expired
or forfeited
|
15,000
|
|
1.27
|
Outstanding
at June 30, 2008
|
2,594,980
|
|
$ 1.36
|
During
the three and nine months ended June 30, 2008, proceeds of $14,000 and $196,250,
respectively, were received from the exercise of stock
options. During the nine months ended June 30, 2007, proceeds
of approximately $96,000 were received from stock option
exercises. No options were exercised during the three months ended
June 30, 2007. The intrinsic value of the options exercised was
$13,000 and $127,200, respectively, for the three and nine months ended June
30,
2008. The intrinsic value of the options exercised during the nine
months ended June 30, 2007 was $46,230. There was no realized tax
benefit from options exercised for the three and nine months ended June 30,
2008
and 2007, based on the “with and without” approach.
The
following table summarizes the stock options outstanding and exerciserable
at
June 30, 2008:
|
Number
Outstanding
At
6/30/08
|
Wghted.
Avg.
Remaining
Life
|
Wghted.
Avg.
Exercise
Price
|
Aggregate
Intrinsic
Value
|
Number
Exerciserable
At
6/30/08
|
Wghted.
Avg.
Exercise
Price
|
Aggregate
Intrinsic
Value
|
Wghted.
Avg.
Remaining
Life
|
Total
|
2,594,980
|
5.03
|
$1.36
|
$ 3,335,225
|
2,532,480
|
$1.37
|
$3,248,975
|
4.95
|
The
aggregate intrinsic value in the table above is before income taxes, based
on
the Company’s closing stock price of $2.65 as of the last business day of the
period ended June 30, 2008. As of June 30, 2008, the Company had
unrecognized compensation expenses of $61,619 related to unvested stock
options. These expenses will be recognized over approximately 1.29
years.
Restricted
Stock
The
Company issues restricted stock to employees and consultants. Such issuances
may
have vesting periods that range from one to two years or the issuances may
be
contingent on continued employment for periods that range from one to two years.
In addition, the Company has issued restricted stock awards to certain employees
that contain vesting provisions.
As
of
June 30, 2008, there was approximately $23,000 of total unrecognized
compensation cost related to non-vested restricted stock compensation
arrangements granted under the incentive and retention plans. The expense will
be recognized over approximately 4 months.
The
Company granted 38,000 shares of restricted stock during the first nine months
of fiscal 2008. The fair value of the awards granted was approximately $88,000.
All such shares of restricted stock vest between September 30 and November
1, 2008, provided the grantee has not voluntarily terminated service or been
terminated for cause prior to the vesting date. The Company granted 236,250
shares of restricted stock during the first nine months of fiscal 2007. The
fair
value of the awards granted was approximately $379,000. All of these shares
vested between September 30, 2007 and April 15, 2008.
The
Company recognized share-based compensation expense for restricted stock of
approximately $41,000 and $238,000 for the three and nine months ended June
30,
2008, respectively, and $225,000 and $594,000 for the three and nine months
ended June 30, 2007, respectively, in selling, general and administrative
expenses in the statements of income for those periods.
No
shares
of restricted stock were forfeited during the three months and nine months
ended
June 30, 2008. During the three and nine months ended June 30, 2007,
2,500 shares of restricted stock were forfeited.
Common
Stock Purchase
Warrants
No
warrants were issued in the three and nine months ended June 30, 2008 or the
same periods in 2007.
During
the nine months ended June 30, 2008, proceeds of $422,500 were received from
the
exercise of warrants. No warrant exercises occurred during the three
months ended June 30, 2008. During the same period in fiscal 2007, no
warrant exercises occurred.
At
June
30, 2008, 1,226,500 warrants were outstanding and exercisable with weighted
average remaining contractual lives of 5.48 years.
NOTE
6 –
Warrant Settlement
Program
During
the third quarter of fiscal 2007, the Company offered certain holders of
warrants a program under which they could settle the warrants for fully vested
common stock. The subject warrants had exercise prices ranging from
$0.40 per share to $1.50 per share. Warrant holders who elected to
participate in the program tendered 2,762,500 warrants to acquire 1,782,645
shares of common stock, which were issued during the third quarter of fiscal
2007. Since the fair value of the warrants tendered was greater than
the value of the common stock received, no expense was recorded related to
this
program.
NOTE
7 -
Stock Repurchase
Program
On
January 17, 2007, the Company announced a Stock Repurchase Program under the
terms of which up to a million shares of its common stock could be purchased
during the subsequent twelve months. Later in 2007, the buy-back period was
extended to December 31, 2008. In late March 2008, the Board approved expansion
of the repurchase program up to a total of 2,000,000 shares to be acquired
through December 31, 2009. Through June 30, 2008, the Company has
purchased 613,000 shares.
Issuer
Purchases of Equity Securities:
|
|
Details
of Treasury Stock Purchases to Date
|
|
Period:
|
|
Total
Number
of
Shares
Purchased
|
|
|
Average
Price
Paid
Per
Share
|
|
|
Total
Number
of
Shares Purchased
As
Part of Publicly
Announced
Program
|
|
|
Maximum
Number
of
Shares that May
Yet
be Purchased
Under
the Program
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January
17, 2007 – September 30, 2007
|
|
|
173,400 |
|
|
$ |
2.12 |
|
|
|
173,400 |
|
|
|
826,600 |
|
October
1, 2007 – December 31, 2007
|
|
|
137,000 |
|
|
$ |
2.59 |
|
|
|
310,400 |
|
|
|
689,600 |
|
January
1, 2008 – March 31, 2008
|
|
|
112,000 |
|
|
$ |
2.45 |
|
|
|
422,400 |
|
|
|
1,577,600 |
|
April
1, 2008 – April 30, 2008
|
|
|
81,400 |
|
|
$ |
2.54 |
|
|
|
503,800 |
|
|
|
1,496,200 |
|
May
1, 2008 – May 31, 2008
|
|
|
58,200 |
|
|
$ |
2.70 |
|
|
|
562,000 |
|
|
|
1,438,000 |
|
June
1, 2008 – June 30, 2008
|
|
|
51,000 |
|
|
$ |
2.67 |
|
|
|
613,000 |
|
|
|
1,387,000 |
|
Quarterly
Subtotal
|
|
|
190,600 |
|
|
$ |
2.62 |
|
|
|
190,600 |
|
|
|
1,387,000 |
|
Total
|
|
|
613,000 |
|
|
$ |
2.44 |
|
|
|
613,000 |
|
|
|
1,387,000 |
|
NOTE
8 –
Repurchase of Class
A
Series 3 Convertible Preferred Stock
In
April
2008, the Company repurchased 150,000 shares of Class A Series 3 Convertible
Preferred Stock, which is subject to a 10% dividend, paid quarterly. The shares
were repurchased at $3.17 per share for a total of approximately
$475,000. The shares were purchased at the same per share price at
which they were sold to the shareholder. The repurchased preferred
shares have been retired. There was no unpaid
dividend as of June 30, 2008 for this repurchase.
NOTE
9 –
Redemption of Class
A
Series 1 Convertible Preferred Stock
In
May
2008, the Company elected to exercise its right to redeem all of the 56,000
outstanding shares of its Class A Series 1 Convertible Preferred
Stock (the "Series 1 Preferred Stock"), subject to the right of the holders
to
elect to convert their shares of Series 1 Preferred Stock into Common Stock
in lieu of redemption. On the redemption dates in
June 2008, 42,000 of the outstanding shares of Series 1 Preferred
Stock were acquired by the Company pursuant to the redemption and
cancelled and the remaining 14,000 outstanding shares of Series 1 Preferred
Stock were converted into 14,000 shares of Common Stock and cancelled. The
Series 1 Preferred Stock was subject to an 8% dividend, paid
annually. The Company paid a redemption price per share equal to the
liquidation value per share (which was $2.50 per share plus accrued and unpaid
dividends) for the 42,000 shares that were redeemed. Shareholders who
elected to convert received one common share for each share of Series 1
Preferred Stock plus accumulated dividends. There
were approximately $2,100 of unpaid dividends for the converted 14,000 shares
of
Series 1 Preferred Stock as of June 30, 2008. These dividends were
paid in July 2008.
NOTE
10 -
Industry Segments
and
Financial Information About Foreign and Domestic Operations
The
Company currently operates primarily in one industry segment which includes
the
development, manufacture and marketing of consumer health care
products.
The
Company operates in foreign and domestic regions. Information about the
Company's operations by geographic area is as follows:
(Amounts
in thousands)
|
|
|
|
Net
Sales to External Customers
For
the Nine months Ended
June
30,
|
|
|
Long-Lived
Assets As of
|
|
|
|
June
30,
|
|
|
September
30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
South
Africa
|
|
$ |
3,367 |
(1)
(2)
|
|
$ |
3,210 |
(1)
|
|
$ |
- |
|
|
$ |
- |
|
Zimbabwe
|
|
|
2,700 |
(1)
|
|
|
2,426 |
(1)
|
|
|
- |
|
|
|
- |
|
France
|
|
|
* |
|
|
|
986 |
|
|
|
- |
|
|
|
- |
|
United
States
|
|
|
1,540 |
|
|
|
1,834 |
(1)
|
|
|
204 |
|
|
|
226 |
|
Brazil
|
|
|
2,077 |
(1)
|
|
|
* |
|
|
|
- |
|
|
|
- |
|
Zambia
|
|
|
* |
|
|
|
843 |
|
|
|
- |
|
|
|
- |
|
Namibia
|
|
|
* |
|
|
|
* |
|
|
|
- |
|
|
|
- |
|
Tanzania
|
|
|
* |
|
|
|
* |
|
|
|
- |
|
|
|
- |
|
India
|
|
|
* |
|
|
|
* |
|
|
|
203 |
|
|
|
225 |
|
United
Kingdom
|
|
|
* |
|
|
|
* |
|
|
|
395 |
|
|
|
315 |
|
Malaysia
|
|
|
* |
|
|
|
* |
|
|
|
950 |
|
|
|
864 |
|
Other
|
|
|
8,110 |
|
|
|
4,847 |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
17,794 |
|
|
$ |
14,146 |
|
|
$ |
1,752 |
|
|
$ |
1,630 |
|
*
Less than 5 percent of total net sales
(1)Comprised
of a customer that is considered to be a major customer (exceeds
10% of
net sales).
(2)$1,505,000
of the revenue amount is a current outstanding accounts receivable
balance
as of June 30, 2008. Thirty-three
percent of the receivable was paid by the date of this
filing.
|
|
NOTE
11 -
Contingent
Liabilities
The
testing, manufacturing and marketing of consumer products by the Company entail
an inherent risk that product liability claims will be asserted against the
Company. The Company maintains product liability insurance coverage for claims
arising from the use of its products. The coverage amount is currently
$5,000,000 for FHC's consumer health care product.
NOTE
12 -
Deferred Grant
Income
The
Company received grant monies from the British Linkage Challenge Fund to help
the Company defray certain expenses and the cost of capital expenditures related
to a specific project. The underlying project relates to the
development of a linkage between the UK subsidiary and HLL in India to do
end-stage manufacturing of the female condom and develop the market for the
product in that country. The grant received was split between the
Company and HLL pro-rata to their respective expenditure on the
project.
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. In the three and nine months ended June 30,
2008, the reimbursement of project-related expenses was zero and $1,836,
respectively, versus $116,788 and $160,302, respectively, in the same periods
of
2007. In the three and nine months ended June 30, 2008, amortization
of deferred grant proceeds were $7,815 and $15,995
respectively. There was no amortization of deferred grant proceeds in
2007.
NOTE
13
– Income
Taxes
The
Company accounts for income taxes using the liability method, which requires
the
recognition of deferred tax assets or liabilities for the tax-effected temporary
differences between the financial reporting and tax bases of our assets and
liabilities, and for net operating loss and tax credit
carryforwards.
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. Our income tax
expense recorded for the three months and nine months ended June 30, 2008 has
been reduced by an offsetting decrease in our valuation allowance. In
the three months and nine months ending June 30, 2008, a tax benefit of $167,000
and $544,000, respectively, was recognized. No tax benefit was
recognized in the three and nine months ended June 30, 2007. We intend to
maintain the remaining valuation allowance until sufficient further positive
evidence exists to support further reversals of the valuation
allowance.
A
reconciliation of income tax expense and the amount computed by applying the
statutory Federal income tax rate to income before taxes as of June 30, 2008
and
June 30, 2007, is as follows:
|
|
June
30
2008
|
|
|
June
30
2007
|
|
|
|
|
|
|
|
|
Income
tax expense at statutory rates
|
|
$ |
700,000 |
|
|
$ |
180,000 |
|
Non-deductible
expenses
|
|
|
76,000 |
|
|
|
73,000 |
|
State
income tax, net of federal benefits
|
|
|
109,000 |
|
|
|
28,000 |
|
Recognition
of net operating loss, decrease in valuation allowance
|
|
|
(544,000 |
) |
|
|
- |
|
Utilization
of NOL carryforwards
|
|
|
(894,000 |
) |
|
|
(506,000 |
) |
Benefit
of net operating loss not recognized, increase in valuation
allowance
|
|
|
9,000 |
|
|
|
225,000 |
|
Income
tax benefit
|
|
$ |
(544,000 |
) |
|
$ |
- |
|
In
September 2006, the Financial Accounting Standards Board (“FASB”) issued
Interpretation No. 48 (FIN 48), Accounting for Uncertainty in Income
Taxes. FIN 48 prescribes a recognition threshold and measurement attribute
for the financial statement recognition and measurement of a tax position taken
or expected to be taken in a tax return. FIN 48 developed a two-step process
to
evaluate a tax position and also provides guidance on de-recognition,
classification, interest and penalties, accounting in interim periods,
disclosure, and transition. The Company adopted this interpretation on
October 1, 2007. The Company has not recorded a reserve for any tax positions
for which the ultimate deductibility is highly certain but for which there
is
uncertainty about the timing of such deductibility. The Company files
tax returns in all appropriate jurisdictions. The open tax years are
those years ending September 30, 2004 to September 30, 2007, which statutes
expire in 2008-2011. As of June 30, 2008, the Company has no recorded
liability for unrecognized tax benefits. The adoption and
implementation of FIN 48 had no effect on the Company’s income from operations,
net income or basic and diluted earnings per share for the period ended June
30,
2008.
The
Company recognizes interest and penalties related to uncertain tax positions
as
income tax expense as incurred. No expense for interest and penalties
was recognized for the nine months ended June 30, 2008.
NOTE
14 -
Recent Accounting
Pronouncements
In
March 2008, the FASB issued SFAS
No. 161, “Disclosures about Derivative Instruments and Hedging Activities”
(SFAS 161) as an amendment to SFAS No. 133, “Accounting for Derivative
Instruments and Hedging Activities”. SFAS 161 requires that objectives for using
derivative instruments be disclosed in terms of underlying risk and accounting
designation. SFAS 161 is effective for financial statements issued for fiscal
years beginning after November 15, 2008. We are currently evaluating
whether adoption of SFAS 161 will have an impact on our consolidated financial
statements.
In
May
2008, the FASB issued FAS No. 162 "The Hierarchy of Generally Accepted
Accounting Principles" ("FAS 162"). FAS 162 identifies the sources of accounting
generally accepted accounting principles in the United States. FAS 162 is
effective sixty days following the SEC's approval of PCAOB amendments to AU
Section 411, "The Meaning of 'Present fairly in conformity with generally
accepted accounting principles'". The Company is currently evaluating the
potential impact, if any, of the adoption of FAS 162 on its consolidated
financial statements.
In
May
2008, the FASB issued SFAS No. 163, “Accounting for Financial Guarantee
Insurance Contracts – An
interpretation of FASB Statement No. 60”. SFAS 163 requires that an insurance
enterprise recognize a claim liability prior to an event of default when there
is evidence that credit deterioration has occurred in an insured financial
obligation. It also clarifies how Statement 60 applies to financial guarantee
insurance contracts, including the recognition and measurement to be used to
account for premium revenue and claim liabilities, and requires expanded
disclosures about financial guarantee insurance contracts. It is effective
for
financial statements issued for fiscal years beginning after December 15, 2008,
except for some disclosures about the insurance enterprise’s risk-management
activities. SFAS 163 requires that disclosures about the risk-management
activities of the insurance enterprise be effective for the first period
beginning after issuance. Except for those disclosures, earlier application
is
not permitted. The adoption of this statement is not expected to have a material
effect on the Company's future reported financial position or results of
operations.
THE
FEMALE HEALTH COMPANY AND SUBSIDIARIES
MANAGEMENT'S
DISCUSSION AND ANALYSIS
General
The
Female Health Company ("FHC" or the "Company") manufactures, markets and sells
the female condom (FC), the only product under a woman's control that is
approved by the U.S. Food and Drug Administration (FDA) to provide dual
protection against unintended pregnancy and sexually transmitted diseases
("STDs"), including HIV/AIDS.
FC
has
undergone extensive testing for efficacy, safety and acceptability, not only
in
the United States but also in many countries around the world. Certain of these
studies show that having FC available allows women to have more options,
resulting in an increase in protected sex acts and a decrease in STDs, including
HIV/AIDS.
The
product is currently sold or available through various channels in 116
countries. It is commercially marketed directly to consumers in 15 countries
by
various country specific partners, including in the United States, the United
Kingdom, Canada and France. Currently, public sector female condom programs
in
various stages are ongoing in over 90 countries.
Product
FC
is
made of polyurethane, a thin but strong material which is resistant to rips
and
tears during use. FC consists of a soft, loose fitting sheath and two flexible
O
rings. One of the rings is used to insert the device and helps to hold it in
place. The other ring remains outside the vagina after insertion. FC lines
the
vagina, preventing skin-to-skin contact during intercourse. FC is pre-lubricated
and disposable and is recommended for use during a single sex act.
In
September 2005, FHC announced that it had completed development of FC2, its
second generation female condom. FC2 has the same physical design, safety and
efficacy profile as FC. Manufactured from a nitrile polymer, FC2 can be produced
more economically than the first generation product. FC2 has received the CE
Mark which allows the Company to market FC2 throughout the European Union
("EU"). In August 2006, the Company was notified by the World Health
Organization (WHO) that after a stringent technical review process regarding
design, product characteristics, quality control and manufacturing technology,
FC2 is in principle being manufactured to at least the same standard as the
polyurethane female condom, FC. In addition, the design and physical
characteristics of FC2, supported by the clinical data, suggest that FC and
FC2
are functionally equivalent, when used correctly. Based on this assessment,
WHO
has stated that FC2 is acceptable for bulk procurement by UN agencies subject
to
the standard quality assurance measures being applied prior to
procurement.
The
FC2
pre-market approval application (PMA) submitted by the Company on January 8,
2008, was accepted for FDA review on January 28, 2008. The acceptance
began the FDA review process, which generally can take up to 180 active review
days. As is typical for the process, the FDA has asked various
questions regarding the submission, to which the Company has
responded. The time during which the FDA awaits answers to its
questions is not counted as active review process time. It is likely that
additional questions will be asked and answered as the FDA works through the
review process. 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.
Raw
Materials
Polyurethane
is the principal raw material the Company uses to produce FC. The Company has
entered into a supply agreement with Deerfield Urethane, Inc. for the purchase
of the Company's requirement of polyurethane. Under this agreement, the parties
negotiate pricing on an annual basis. While the term of the agreement expires
on
December 31, 2008, the agreement automatically renews for additional one year
periods unless either party gives at least 12 months prior written notice of
termination.
The
principal raw material used to produce FC2 is a nitrile polymer. While general
nitrile formulations are available from a number of suppliers, the Company
chose
to work closely with the technical market leader in synthetic polymers to
develop a grade ideally suited to the bio-compatibility and functional needs
of
a female condom. The supplier has agreed that the Company is the sole
and exclusive owner of the unique polymer formulation that was developed for
FC2.
Global
Market Potential
It
is
more than twenty years since the first clinical evidence of AIDS was noted.
HIV/AIDS is the most devastating pandemic that humankind has faced in recorded
history. The Joint United Nations Programme on HIV/AIDS (“UNAIDS”) in its
December 2007 Aids Epidemic Update reported that 33 million people globally
were living with HIV. Approximately 2.5 million new cases of HIV will be
reported this year while about 2 million people will have died from the disease.
Women now comprise the majority of the new cases in many areas of the world.
In
a published paper by Dr. Colin Mathers and Dejan Loncar of the WHO, “Projections
of Global Mortality and Burden of Disease from 2002 to 2030," they estimate
that
at least 117 million people will have died of or will have AIDS by
2030.
In
2006,
the U.S. Centers for Disease Control and Prevention (CDC) reported that the
HIV/AIDS epidemic is taking an increasing toll on women and girls in the United
States. Women of color, particularly Black women, have been
especially hard hit and represent the majority of new HIV and AIDS cases among
women, and the majority of women living with the disease. Black women
accounted for 67% of AIDS cases among women aged 13 and older diagnosed in
2005,
but only 12% of the U.S. population of women. Latinas accounted for
16% of estimated AIDS cases in 2005, compared to 13% of the female population
aged 13 and over.
For
the
most recent year in which data are available (2004), CDC reported that HIV
infection was:
|
·
|
the
leading cause of death for African American women aged 25-34 years;
|
|
·
|
the
3rd
leading cause of death for African American women aged 35-44 years;
and
|
|
·
|
the
4th
leading cause of death for African American women aged 45-54 years
and for
Hispanic women aged 35-44.
|
Most
HIV/AIDS diagnoses among women are due to high-risk heterosexual contact (80%
in
2005). The rate of AIDS diagnosis for black women was approximately
23 times the rate for white women and 4 times the rate for Hispanic
women.
In
March
2008, CDC announced that a recent study indicated that 26% of female adolescents
in the United States have at least one of the most common sexually transmitted
infections (STI’s). Led by CDC’s Sara Forhan, the study is the first
to examine the combined national prevalence of common STI’s among adolescent
women in the United States.
In
addition to overall STI prevalence, the study found that by race, African
American teenage girls had the highest prevalence, with an overall prevalence
of
48 percent compared to 20 percent among both whites and Mexican
Americans. Overall, approximately half of all the teens in the study
reported ever having sex. Among these girls, the STI prevalence was
40 percent.
The
Condom Market
The
global male condom market (public and private sector) is estimated to be $3
billion. The global public sector market for male condoms is estimated to be
between 11 and 13 billion units annually. Given the rapid spread of HIV/AIDS
in
India and China, UNAIDS estimates that the annual public sector demand for
condoms, both male and female, will reach 19 billion units within the next
ten
years.
The
FC
Female Condom and the Male Condom
Currently,
there are only three FDA approved products marketed that prevent the
transmission of HIV/AIDS through sexual intercourse: the male latex condom,
the
male polyurethane condom and the FC female polyurethane condom. FC is the only
FDA approved product whose use is controlled by women that prevents sexually
transmitted diseases including HIV/AIDS. It provides women dual protection
against STD’s (including HIV/AIDS) and unintended pregnancy. It is also an
alternative when male condoms are not used for reasons of latex sensitivity
or
choice.
Studies
show that both FC’s polyurethane and FC2’s nitrile polymer are safe, strong
materials and that method failure rates are similar to that of male
condoms. The female condom offers a number of benefits over natural
rubber latex, the material that is most commonly used in male condoms. Unlike
natural rubber latex, both polyurethane and the nitrile polymer quickly transfer
heat, so the female condom immediately warms to body temperature when it is
inserted, which may enhance pleasure and sensation during use. Unlike the male
condom, the female condom may be inserted in advance of arousal, eliminating
disruption during sexual intimacy. It is not dependent on the male erection,
does not require immediate withdrawal and is not tight or
constricting. The female condoms can be used with both oil and
water-based lubricants, unlike natural rubber latex male condoms which can
be
used with water-based lubricants only. The products also offer an
alternative to natural rubber latex sensitive users (7% to 20% of the
population) who are unable to use male condoms without irritation. To the
Company's knowledge, there is no reported allergy to either FC polyurethane
or
the FC2 nitrile polymer.
Numerous
clinical and behavioral studies have been conducted regarding use of FC. Studies
show that FC is found acceptable by women and their partners in many cultures.
Importantly, studies also show that when FC is made available as an option
to
using male condoms there is a significant increase in protected sex acts.
The increase in protected sex acts varies by country and averages between 10%
and 35%.
Cost
Effectiveness
A
study
entitled "Cost-effectiveness of the female condom in preventing HIV and STDs
in
commercial sex workers in South Africa" was reported in the Journal of Social Science
and
Medicine in 2001. This study shows that making FC available is highly
cost effective in reducing public health costs in developing countries as well
as in the U.S.
In
October 2006, a study regarding FC2 entitled “Country-wide distribution of the
nitrile female condom (FC2) in Brazil and South Africa: a cost effectiveness
analysis” was published in AIDS. The study concludes
that expanded distribution of FC2 in Brazil and South Africa may avert hundreds
to thousands of HIV infections annually at an incremental cost to government
or
donors that is less than that of antiretroviral therapy. The study also found
that if only 16.6 million female condoms were distributed in
South
Africa, almost 10,000 HIV infections would be prevented. If 53.7 million female
condoms were distributed, 32,000 HIV infections would be prevented. Comparing
the dollar value of health care costs averted with the cost of distributing
the
female condoms, the total cost savings would be between $5.3 million and $35.7
million. Similarly, if 26.2 million female condoms were distributed in Brazil,
600 HIV infections would be averted. If 84.8 million female condoms were
distributed, 2,000 new HIV infections would be prevented. In total, the savings
in Brazil alone could range from $1.1 million to $27 million.
Female
Condom Reuse
Studies
have shown that FC can be reused up to five times. WHO’s website includes the
proper procedure for the washing and preparation of FC if it is going to be
reused. WHO, UNAIDS and FHC concur that FC should only be reused when a new
female condom is not available. FC2 is not reusable.
Worldwide
Regulatory Approvals
FC
received Pre-Market Approval ("PMA") as a Class III Medical Device from the
FDA
in 1993. The extensive clinical testing and scientific data required for FDA
approval laid the foundation for approvals throughout the rest of the world,
including receipt of a CE Mark in 1997 which allows the Company to market FC
throughout the European Union. In addition to the United States and the EU,
several other countries have formally reviewed and approved FC for sale,
including Canada, Australia, Japan and India.
The
Company believes that FC's PMA and FDA classification as a Class III Medical
Device create a significant barrier to entry in the U.S. market. The Company
estimates that it would take a minimum of four to six years to implement,
execute and receive FDA approval of a PMA to market another type of female
condom.
FC2
received the CE mark which allows it to be marketed throughout the European
Union. FC2 has also been approved by regulatory authorities in both Brazil
and
India. The Company submitted a pre-market approval application (PMA) for FC2
which was accepted for FDA review on January 28, 2008.
The
Company believes there are no material issues or material costs associated
with
the Company's compliance with environmental laws related to the manufacture
and
distribution of FC and FC2.
Strategy
The
Company’s strategy is to fully develop the market for FC and FC2 on a global
basis. In doing so, it has developed contacts and relationships with global
public health sector organizations such as WHO, the United Nations Population
Fund (UNFPA), UNAIDS, the U.S. Agency for International Development (USAID),
country-specific health ministries and non-governmental organizations (NGOs),
and commercial partners in various countries. Because the Company has unique
distribution channels and minimum sales and marketing expense, volume increases
will not result in a corresponding increase in operating expenses. To
provide its customers with technical sales support, the Company has placed
representatives in the major regions of the world: Asia, Africa, Europe, North
America and Latin America. The Company manufactures the first generation
product, FC, in London, England. The second generation product, FC2, is being
manufactured in Selangor D.E., Malaysia and in conjunction with FHC’s partner
Hindustan Latex Limited ("HLL"), in Kochi, India.
To
accelerate market penetration and increase volume, the Company developed FC2,
a
nitrile polymer product which is less costly to manufacture than FC. In August
2006, the Company received notice from WHO that after a stringent technical
review process regarding design, product characteristics, quality control and
manufacturing technology, FC2 is in principle being manufactured to at least
the
same standard as the polyurethane female condom, FC. In addition, the design
and
physical characteristics of FC2, supported by the clinical data, suggest that
FC
and FC2 are functionally equivalent, when used correctly. Based on this
assessment, WHO has stated that FC2 is acceptable for bulk procurement by UN
agencies subject to the standard measures being applied prior to
procurement.
Commercial
Markets - Direct to Consumers
The
Company markets FC directly in the United Kingdom. The Company has distribution
agreements with commercial partners which market directly to consumers in 15
countries, including the United States, Brazil, Canada, Mexico, Spain, France,
Japan and India. These agreements are generally exclusive for a single country.
Under these agreements, the Company manufactures and sells the female condom
to
the distribution partners, who, in turn market and distribute the product to
consumers in the established territory.
Relationships
and Agreements with Public Sector Organizations
The
Company has an agreement with UNAIDS to supply FC to developing countries at
a
reduced price which can be negotiated each year based on the Company's cost
of
production. The current price per unit ranges between £0.42 and £0.445 (British
pounds sterling), or approximately $0.84 to $0.89, depending on contractual
volumes. Under the agreement, UNAIDS and the Company cooperate in educational
efforts and marketing FC in developing countries. Sales of FC are made directly
to international public agencies and to public health authorities in each
country at the price established by the agreement with UNAIDS. The agreement
expires on December 31, 2008, but is automatically renewed for one year
unless either party gives at least 90 days prior written notice of termination.
FC is available in over 90 countries through public sector
distribution.
In
May
2006, the Company received an initial order for 500,100 FC female condoms from
the National AIDS Control Organization (NACO) of the Ministry of Health &
Family Welfare, Government of India. The order, placed through UNFPA,
supplied female condoms for NACO’s year-long pre-program prevention and
acceptability study. The female condoms were distributed to 60,000
women at 13 sites in eight states. Because the pilot project was highly
successful showing consistent use of FC, NACO decided to scale up the program
under which women are trained on how to use the Female Condom. In June 2008,
the
Company’s technical collaboration with HLL in India was successful in winning an
order from the National AIDS Control Organization of India. The
order, for 1.5 million female condoms, will be manufactured in Kochi,
India, in HLL’s newly commissioned factory and used in the scaled up prevention
program.
The
Company sells the female condom in the United States to city and state public
health clinics as well as not-for-profit organizations such as Planned
Parenthood. The female condom is currently available in 95 locations
in New York City, including both community based organizations and the N.Y.C.
Department of Health and Mental Hygiene units. It is being
distributed as part of New York City’s Female Condom Education and Distribution
Project being conducted by the Bureau of HIV/AIDS Prevention and
Control. In June 2008, the New York City Department of Health &
Mental Hygiene awarded the Company a bid for two million female condoms for
use
in that program. The program may be increased at the discretion of
the NYC Department of Health.
Manufacturing
Facilities
FC
The
Company manufactures FC in a 40,000 square-foot leased facility in London,
England. Manufacturing capacity at this facility is expandable to
60 million units per year at a capital expenditure of less than $1 million
for the purchase of additional equipment.
FC2
The
Company began end-stage production of FC2 within a 1,900 square foot leased
facility located in Selangor D.E., Malaysia. On September 1, 2007, the
Company leased 16,000 sq. ft. of a production facility, also in Selangor D.E.,
Malaysia, to house the expanding manufacturing. Operations were re-located
to
the newly leased facility in December 2007, at which time the lease on the
original space terminated. The Company’s FC2 manufacturing capacity
in Malaysia is 30 million units annually.
The
Company’s India-based FC2 end-stage production capacity is located at a facility
owned by its India business partner, HLL in the Kochi Special Export Zone.
Production began at that facility in December 2007. The present
FC2 capacity at that facility is 7.5 million units per year. Under an interim
agreement, HLL is authorized to produce FC2 for sale in India in exchange for
a
royalty per unit. The companies are in the process of negotiating a
permanent agreement such as a joint venture which does require the approval
of
the Indian government.
FHC’s
total FC2 production capacity is currently 37.5 million units
annually. The Company intends to expand its capacity at existing
locations and/or manufacture at additional locations as the demand for FC2
increases.
Government
Regulation
In
the
U.S., FC is regulated by the FDA. Pursuant to section 515(a)(3) of the Safe
Medical Amendments Act of 1990 (the "SMA Act"), the FDA may temporarily suspend
approval and initiate withdrawal of the PMA if the FDA finds that FC is unsafe
or ineffective, or on the basis of new information with respect to the device,
which, when evaluated together with information available at the time of
approval, indicates a lack of reasonable assurance that the device is safe
or
effective under the conditions of use prescribed, recommended or suggested
in
the labeling. Failure to comply with the conditions of FDA approval invalidates
the approval order. Commercial distribution of a device that is not in
compliance with these conditions is a violation of the SMA Act. The Company
submitted a pre-market approval application (PMA) for FC2 which was accepted
for
FDA review on January 28, 2008.
Competition
The
Company's female condom participates in the same market as male condoms but
is
not seen as directly competing with male condoms. Rather, the Company believes
that providing FC is additive in terms of prevention and choice. Latex male
condoms cost less and have brand names that are more widely recognized than
FC.
In addition, male condoms are generally manufactured and marketed by companies
with significantly greater financial resources than the Company.
Medtech
Products Ltd. ("MP"), a male latex condom company with a manufacturing facility
in Chennai, India, has developed a natural latex female condom. MP's female
condom has been marketed under various names including V-Amour, VA Feminine
Condom and L’Amour. PATH, an international, nonprofit organization based in the
United States, has a female condom product in early stage
development. USAID and Family Health International (FHI) are
currently evaluating the MP female condom for consideration along with the
PATH
woman’s condom and FC2 to qualify for an in-depth Phase 3 clinical study
evaluation. The MP product’s manufacturing process has a CE mark for
distribution in Europe and may be available in other countries. MP received
the
Indian Drug Controller approval in January 2003. Neither the MP female condom
nor the PATH woman’s condom have received FDA approval or been listed as
essential products for procurement by WHO.
It
is
also possible that other parties may develop a female condom. These competing
products could be manufactured, marketed and sold by companies with
significantly greater financial resources than those of the
Company.
Patents
and Trademarks
The
Company currently holds product and technology patents for FC in the United
States. The Company’s current United States patents expire between 2009 and
2014. The Company understands these U.S. patents to cover FC as sold. The
patents are generally directed to the structural aspects of the product.
While there can be no assurance, these patents could provide the Company with
protection against copycat products entering the U.S. market during the pendency
of the patents. The Company also has patents covering technology and products
relating to FC in Japan, the United Kingdom, France, Italy, Germany, Spain,
the
European Patent Convention, Canada, the People’s Republic of China, South Korea
and Australia. These patents expire from 2008 to
2013. Patent applications for FC2 are pending in the U.S. and in
other countries around the world through the Patent Cooperation Treaty. The
applications cover the key aspects of the second generation female condom,
including its overall design and manufacturing process.
The
Company has the registered trademark “FC Female Condom” in the United
States. The Company has also secured, or applied for, 12 trademarks in 22
countries to protect the various names and symbols used in marketing the product
around the world. These include "femidom" and "femy", “Reality” and others. In
addition, the experience that has been gained through years of manufacturing
the
FC female condom has allowed the Company to develop trade secrets and know-how,
including certain proprietary production technologies that further secure its
competitive position. The Company has registered the trademark “FC2 Female
Condom” in the United States.
Overview
The
Company manufactures, markets and sells the FC female condom, the only
FDA-approved product under a woman's control which provides dual protection
against unintended pregnancy and sexually transmitted diseases, including
HIV/AIDS. During 2003, the Company started developing a second
generation female condom, FC2, which was completed in 2006. The first
substantial sales of FC2 occurred in the second quarter of fiscal 2007.The
Company believes that availability of the lower priced FC2 will accelerate
growth while increasing prevention for women and improving
profitability.
Revenues. Most
of
the Company's revenues are derived from sales of the female condom, its only
product, and are recognized upon shipment of the product to its customers.
Beginning in fiscal 2008, the Company also derives revenue from licensing its
intellectual property. Such revenue appears as royalty income on the
Unaudited Condensed Consolidated Statements of Income for the three and nine
months ended June 30, 2008.
The
Company's strategy is to develop a global market and distribution network for
its product by completing partnership arrangements with companies with the
necessary marketing and financial resources and local market
expertise. The Company's customers include the
following:
|
·
|
The
Company sells the female condom to the global public sector under
the
umbrella of its agreement with UNAIDS. This agreement facilitates
the
availability and distribution of the female condom at a reduced price
based on the Company's cost of production. The current price per
unit
ranges between £0.42 and £0.445 (British pounds sterling), or
approximately $0.84 to $0.89. Currently, the female condom is
available in over 90 countries through public sector distribution.
|
|
·
|
The
Company sells FC to the U.S. Agency for International Development
(USAID)
for use in USAID prevention programs in developing countries.
|
|
·
|
The
Company sells the female condom in the United States to city and
state
public health clinics as well as not-for-profit organizations such
as
Planned Parenthood. The female condom is currently available in 95
locations in New York City, including both community-based organizations
and the N.Y.C. Department of Health and Mental Hygiene units. It
is being
distributed as part of New York City‘s Female Condom Education and
Distribution Project being conducted by the Bureau of HIV/AIDS Prevention
and Control. In June 2008, the New York City Department of
Health & Mental Hygiene awarded the Company a bid for two million
female condoms for use in that program.
|
|
·
|
The
Company markets FC directly in the United Kingdom. The Company has
distribution agreements with commercial partners which market directly
to
consumers in 15 countries, including the United States, Brazil, Canada,
Mexico, Spain, France, Japan and India. These agreements are generally
exclusive for a single country. Under these agreements, the Company
manufactures and sells the female condom to the distributor partners,
who,
in turn market and distribute the product to consumers in the established
territory.
|
Quarterly
financial results may vary significantly from one quarter to another due to
the
timing and shipment of large orders rather than from any fundamental change
in
the Company's business. Because the Company manufactures FC in a
leased facility located in London, England and FC2 in a leased facility located
in Malaysia, a portion of the Company's operating costs occur in foreign
currencies. While a material portion of the Company's future sales are likely
to
be global versus domestic, all sales are denominated in British pounds sterling
or United States dollars only. Manufacturing costs and sales to foreign markets
are subject to normal currency risks associated with changes in the exchange
rate of the British pound sterling relative to the United States dollar. For
the
first nine months of fiscal 2008, 58% of the Company’s net revenues, 84% of the
Company’s cost of products sold and 31% of the Company’s operating expenses were
affected by changes in the exchange rate of foreign currencies relative to
the
United States dollar.
On
an
ongoing basis, management continues to evaluate its commercial transactions
and
is prepared to employ currency hedging strategies when it believes such
strategies are appropriate. In addition, some of the Company's future
international sales may be in developing nations where dramatic political or
economic changes are possible. Such factors may adversely affect the Company's
results of operations and financial condition. For the first nine months of
fiscal 2008, the Company estimates that the net adverse impact of the exchange
rate fluctuations was not significant.
Expenses. The
Company manufactures FC at its facility located in the United Kingdom and FC2
at
its facility located in Selangor D.E., Malaysia. The Company's cost
of products sold consists primarily of direct material costs, direct labor
costs
and indirect production and distribution costs. Direct material costs
include raw materials used to make the female condom, principally polyurethane
for FC and a nitrile polymer for FC2. Indirect product costs include
logistics, quality control, and maintenance expenses, as well as costs for
helium, nitrogen, electricity and other utilities. All of the key
components for the manufacture of the female condom are essentially available
from either multiple sources or multiple locations within a source.
The
Company’s costs of sales, supplies, salaries and benefits, and general and
administrative expenses have increased. In the first nine months of
fiscal 2008, the Company has, where possible, increased selling prices to offset
such increases in costs.
As
noted
above, the Company's manufacturing costs are subject to currency risks
associated with changes in the exchange rate of British pounds sterling relative
to the United States dollar. To date, the Company's management has
not deemed it necessary to utilize currency hedging strategies to manage its
currency risks. A decrease of the value of the U.S. dollar compared
to British pounds sterling has the effect of increasing the Company's cost
of
sales and decreasing its gross profit margin.
RESULTS
OF
OPERATIONS
THREE
MONTHS ENDED JUNE 30, 2008 COMPARED TO THREE MONTHS ENDED JUNE 30,
2007
The
Company had net revenues of $5,658,125 and net income attributable to common
stockholders of $509,067, or $0.02 per diluted share, for the three months
ended
June 30, 2008 compared to net revenues of $4,623,190 and net income attributable
to common stockholders of $317,274, or $0.01 per diluted share, for the three
months ended June 30, 2007.
Gross
profit increased $364,826, or 20%, to $2,177,725 for the three months ended
June
30, 2008 from $1,812,899 for the three months ended June 30, 2007. Gross profit
for the three months ended June 30, 2008 was positively impacted by increased
volume.
Net
revenues increased $1,034,935, or 22%, for the three months ended June 30,
2008
compared with the same period last year. The revenue increase is primarily
attributable to growth in demand.
Significant
quarter to quarter variations result from time to time due to the timing and
shipment of large orders and production scheduling rather than fundamental
change in the business. The Company routinely notes the potential for such
variations in its press releases and SEC filings.
Cost
of
sales increased $670,109, or 24%, to $3,480,400 for the three months ended
June
30, 2008 from $2,810,291 for the same period last year. The increase is due
primarily to increased unit sales, and to a lesser extent, increased costs
of
labor and materials.
Advertising
and promotion expenditures increased $12,913 to $50,969 for the three months
ended June 30, 2008 from $38,056 for the same period in the prior year. The
increase relates to a public relations program designed to increase product
awareness in specific locations.
Selling,
general and administrative expenses increased $344,176, or 25%, to $1,715,515
for the three months ended June 30, 2008 from $1,371,339 for the three months
ended June 30, 2007. During the third quarter of fiscal 2008, FHC
recorded an expense accrual for incentive compensation based on the probability
of achievement of fiscal 2008 plan compared to the third quarter of fiscal
2007
when there was a reversal of an expense accrual due to a change in accounting
estimate. A year-to-year comparison of operating expense shows a
23.5% increase, 71% of which is attributable to the accrual mentioned
above. Costs in the 2008 quarter also increased due to Sarbanes-Oxley
404 compliance consulting fees.
Research
and development cost decreased $18,062 to $14,865 for the three months ended
June 30, 2008 from $32,927 for the same period in the prior year. The third
quarter costs in both fiscal year 2007 and fiscal year 2008 are related to
the
FC2 PMA submission.
Operating
income for the three months ended June 30, 2008, was $396,376 versus $370,577
in
the same period last year, an increase of $25,799 or 7%. The increase
was primarily due to the improved gross profit reduced by the increased
operating expenses.
Interest,
net and other income for the three months ended June 30, 2008 was $13,964,
a
change of $3,160 from the same period in fiscal year 2007, when net interest
income was $10,804. The impact of foreign currency transactions for
the third quarter of fiscal year 2008 was a loss of $36,680 compared to a loss
of $23,905 for the same period last year.
Under
the
Statement of Financial Accounting Standards No. 109, Accounting for Income
Taxes, an entity is able to recognize a tax benefit for current or past losses
when it can demonstrate that the tax loss carry forward will be utilized before
expiration. Management believes that the Company's recent and
projected future growth and profitability has made it more likely than not
that
the Company will utilize its net operating carryforwards in the
future. The Company has recorded a tax benefit in the amount of
$167,000 during the three months ended June 30, 2008.
NINE
MONTHS ENDED JUNE 30, 2008 COMPARED TO NINE MONTHS ENDED JUNE 30,
2007
The
Company had net revenues of $17,794,153 and net income attributable to common
stockholders of $2,488,971, or $0.09 per diluted share, for the nine months
ended June 30, 2008 compared to net revenues of $14,145,663 and net income
attributable to common stockholders of $407,698, or $0.02 per diluted share,
for
the nine months ended June 30, 2007.
Gross
profit increased $2,091,094 or 41%, to $7,216,488 for the nine months ended
June
30, 2008 from $5,125,394 for the nine months ended June 30,
2007. Gross profit for the nine months ended June 30, 2008 was
positively impacted by product mix, with a higher percentage of FC2 unit sales
in 2008 versus the same period last year. The improved FC average
sales price per unit in the nine months ended June 30, 2008, compared to the
same period in fiscal year 2007 also enhanced the gross margin.
Net
revenues increased $3,648,490, or 26%, for the nine months ended June 30, 2008
compared with the same period last year. The stronger revenue performance
reflects the increased global demand for the female condom.
Significant
quarter to quarter variations result from time to time due to the timing and
shipment of large orders and production scheduling rather than fundamental
change in the business. The Company routinely notes the potential for such
variations in its press releases and SEC filings.
Cost
of
sales increased $1,557,396 or 17%, to $10,577,665 for the nine months ended
June
30, 2008 from $9,020,269 for the same period last year. The increase is mainly
derived from increased unit sales, higher direct material, labor and indirect
production costs as well as one-time costs of approximately $55,000 related
to
the move to and start-up of the new Malaysian facility.
Advertising
and promotion expenditures increased $30,325 to $161,345 for the nine months
ended June 30, 2008 from $131,020 for the same period in the prior year. The
increase relates to public relations program designed to raise product awareness
in specific locations.
Selling,
general and administrative expenses increased $563,032, or 13%, to $4,899,747
for the nine months ended June 30, 2008 from $4,336,715 for the nine months
ended June 30, 2007. The Company incurred higher employee-related costs due
to
staff expansion in the past twelve months as well as some consulting fees
related to Sarbanes-Oxley 404 compliance.
Research
and development cost increased $45,573 to $202,241 for the nine months ended
June 30, 2008 from $156,668 for the same period in the prior year. The costs
in
2007 relate both to initiating commercial production of FC2 in Malaysia and
preparation of the FC2 PMA submission. Expenses incurred in
fiscal 2008 relate to preparation of the FC2 PMA and the one-time FDA PMA
application fee of $46,250.
For
the
nine months ended June 30, 2008, operating income was $1,953,155, an increase
of
$1,452,164, or 290%, over operating income of $500,991 in the same period last
year. The increase was due to higher volume and improved gross margin, somewhat
offset by the increased operating expenses.
Interest,
net and other income for the nine months ended June 30, 2008 was $30,629, a
change of $4,591 from the same period in fiscal year 2007, when net interest
income was $35,220. The foreign currency transaction impact for the
nine months ended June 30, 2008 was a net gain of $73,625 compared to a loss
of
$7,908 for the same period last year.
Under
the
Statement of Financial Accounting Standards No. 109, Accounting for Income
Taxes, an entity is able to recognize a tax benefit for current or past losses
when it can demonstrate that the tax loss carry forward will be utilized before
expiration. Management believes that the Company's recent and
projected future growth and profitability has made it more likely than not
that
the Company will utilize its net operating carryforwards in the
future. The Company has recorded a tax benefit in the amount of
$544,000 during the nine months ended June 30, 2008.
Factors
That May Affect Operating Results and Financial Condition
The
Company's future operating results and financial condition are dependent on
the
Company's ability to increase demand for the female condom and to
cost-effectively manufacture sufficient quantities of the female condom.
Inherent in this process are a number of factors that the Company must
successfully manage in order to achieve favorable future results and improve
its
financial condition.
Reliance
on a Single Product
The
Company expects to derive the vast majority, if not all, of its future revenues
from the female condom, its sole current product. While management believes
the
global potential for the female condom is significant, the ultimate level of
consumer demand around the world is not yet known.
Distribution
Network
The
Company has developed a global distribution network for the female condom by
entering into partnership arrangements with financially secure companies with
appropriate marketing expertise. This strategy has resulted in numerous
in-country distributions in the public sector, particularly in Africa, Latin
America and India. The Company has also entered into several agreements for
the
commercialization of the female condom in consumer sector markets around the
world. However, the Company is dependent on country governments and global
donors, as well as U.S. municipal and state public health departments to
continue AIDS/HIV/STD prevention programs that include female condoms as a
component of such programs. The Company’s commercial market penetration is
dependent on its ability to identify appropriate business partners who will
effectively market and distribute the female condom within its contractual
territory. Failure by the Company's partners to successfully market and
distribute the female condom or failure of country governments to establish
and
sustain HIV/AIDS prevention programs which include distribution of female
condoms, the Company’s inability to secure additional agreements with global
AIDS prevention organizations, or the Company’s inability to secure agreements
in new markets, either in the public or private sectors, could adversely affect
the Company’s financial condition and results of operations.
Inventory
and Supply
All
of
the key components for the manufacture of the female condom are essentially
available from either multiple sources or multiple locations within a
source.
Global
Market and Foreign Currency Risks
The
Company manufactures FC in a leased facility located in London, England and
FC2
in a leased facility located in Malaysia. A material portion of the Company's
future sales are likely to be in foreign markets. Manufacturing costs and sales
to foreign markets are subject to normal currency risks associated with changes
in the exchange rate of foreign currencies relative to the United States dollar.
For the first nine months of fiscal 2008, 58% of the Company’s net revenues, 84%
of the Company’s cost of products sold and 31% of the Company’s operating
expenses were affected by changes in the exchange rate of foreign currencies
relative to the United States dollar.
For
the
first nine months of fiscal 2008, the Company estimates that the net adverse
impact of the exchange rate fluctuations was not significant. On an
ongoing basis, management continues to evaluate its commercial transactions
and
is prepared to employ currency hedging strategies when it believes such
strategies are appropriate. In addition, some of the Company's future
international sales may be in developing nations where dramatic political or
economic changes are possible. Such factors may adversely affect the Company's
results of operations and financial condition.
Government
Regulation
The
female condom is subject to regulation by the FDA pursuant to the federal Food,
Drug and Cosmetic Act (the "FDC Act"), and by other state and foreign regulatory
agencies. Under the FDC Act, medical devices must receive FDA clearance before
they can be sold. FDA regulations also require the Company to adhere to certain
"Good Manufacturing Practices," which include testing, quality control and
documentation procedures. The Company's compliance with applicable regulatory
requirements is monitored through periodic inspections by the FDA. The failure
to comply with applicable regulations may result in fines, delays or suspensions
of clearances, seizures or recalls of products, operating restrictions,
withdrawal of FDA approval and criminal prosecutions. The Company's operating
results and financial condition could be materially adversely affected in the
event of a withdrawal of approval from the FDA.
Liquidity
and Sources of Capital
In
the
first nine months of fiscal 2008, the Company generated $2.6 million in positive
cash flow from operations as a result of increased sales volume and improved
gross margins. During the first nine months of fiscal 2007, cash provided by
operations was $0.7 million.
Accounts
receivable decreased from $6,080,153 at September 30, 2007 to $5,964,736 at
June 30, 2008. The Company's quarter-end accounts receivable balance
is impacted by various factors besides rising sales levels. One
factor is the Company's pattern of production and delivery, which causes
accounts receivable to increase near quarter end. The Company's U.K.
subsidiary produces U.S. labeled FC early in the quarter to be sold by its
U.S.
parent to customers within the U.S., thus contributing to their
sales. The Company tends to produce and ship FC to ex-U.S. customers
and the United States Agency for International Development (USAID) later in
the
quarter, causing quarter-end increases in receivables. The timing of
large orders can have a significant impact on the quarter-end
balance. The Company's standard credit terms vary from 30 to 90 days,
depending on the class of trade and customary terms within a territory, so
the
accounts receivable balance is also affected by the mix of purchasers within
the
quarter. As is typical in the Company's business, extended credit
terms may occasionally be offered as a sales promotion. For the past
twelve months, the Company's average days sales outstanding has been
approximately 94. Over the past five years, the Company’s bad debt expense
has been less than .01% of sales.
At
June
30, 2008, the Company had working capital of $8.4 million and stockholder’s
equity of $8.9 million compared to working capital of $7.1 million and
stockholder’s equity of $7.4 million as of September 30, 2007.
The
Company believes its current cash position is adequate to fund operations of
the
Company in the near future, although no assurances can be made that such cash
will be adequate. However, the Company may sell equity securities to raise
additional capital and may borrow funds under its Heartland Bank credit
facility.
Presently,
the Company has two revolving notes with Heartland Bank, expiring July 1, 2009,
that allow the Company to borrow up to $1,500,000. These notes were extended
under the same terms as the initial notes dated May 19, 2004, with the exception
of the interest rate which has been reduced to prime plus 0.5% (prime rate
was
5% at June 30, 2008). No new warrants were issued as part of the extension
of
these notes. These notes are collateralized by substantially all of the assets
of the Company. No amounts were outstanding under the revolving notes at June
30, 2008.
Impact
of
Inflation and Changing Prices
Although
the Company cannot accurately determine the precise effect of inflation, the
Company has experienced increased costs of product, supplies, salaries and
benefits, and increased general and administrative expenses. In fiscal year
2007
and 2008 the Company has, where possible, increased selling prices to offset
such increases in costs.
As
of the
end of the period covered by this report, the Company carried out an evaluation,
under the supervision and with the participation of the Company's management,
including the Company's Chief Executive Officer and the Company's Chief
Financial Officer, of the effectiveness of the design and operation of the
Company's disclosure controls and procedures (as defined in Rules 13a-15(e)
and
15d-15(e) under the Securities Exchange Act of 1934, as amended). Based on
this
evaluation, the Company's Chief Executive Officer and Chief Financial Officer
concluded that the Company's disclosure controls and procedures were effective.
It should be noted that in designing and evaluating the disclosure controls
and
procedures, management recognized that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and management necessarily was
required to apply its judgment in evaluating the cost-benefit relationship
of
possible controls and procedures. The Company has designed its disclosure
controls and procedures to reach a level of reasonable assurance of achieving
desired control objectives and, based on the evaluation described above, the
Company's Chief Executive Officer and Chief Financial Officer concluded that
the
Company's disclosure controls and procedures were effective at reaching that
level of reasonable assurance.
There
was
no change in the Company's internal control over financial reporting (as defined
in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934,
as
amended) during the Company's most recently completed fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the Company's
internal control over financial reporting.
PART
II - OTHER
INFORMATION
Items
1-5.
Item
2(c)
On
January 17, 2007, the Company announced a Stock Repurchase Program under the
terms of which up to a million shares of its common stock could be purchased
during the subsequent twelve months. Later in 2007, the buy-back period was
extended to December 31, 2008. In late March 2008, the Board approved expansion
of the repurchase program up to a total of 2,000,000 shares to be acquired
through December 31, 2009. Through June 30, 2008, the Company has
purchased 613,000 shares.
Issuer
Purchases of Equity Securities:
|
|
Details
of Treasury Stock Purchases to Date
|
|
Period:
|
|
Total
Number
of
Shares
Purchased
|
|
|
Average
Price
Paid
Per
Share
|
|
|
Total
Number
of
Shares Purchased
As
Part of Publicly
Announced
Program
|
|
|
Maximum
Number
of
Shares that May
Yet
be Purchased
Under
the Program
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January
17, 2007 – September 30, 2007
|
|
|
173,400 |
|
|
$ |
2.12 |
|
|
|
173,400 |
|
|
|
826,600 |
|
October
1, 2007 – December 31, 2007
|
|
|
137,000 |
|
|
$ |
2.59 |
|
|
|
310,400 |
|
|
|
689,600 |
|
January
1, 2008 – March 31, 2008
|
|
|
112,000 |
|
|
$ |
2.45 |
|
|
|
422,400 |
|
|
|
1,577,600 |
|
April
1, 2008 – April 30, 2008
|
|
|
81,400 |
|
|
$ |
2.54 |
|
|
|
503,800 |
|
|
|
1,496,200 |
|
May
1, 2008 – May 31, 2008
|
|
|
58,200 |
|
|
$ |
2.70 |
|
|
|
562,000 |
|
|
|
1,438,000 |
|
June
1, 2008 – June 30, 2008
|
|
|
51,000 |
|
|
$ |
2.67 |
|
|
|
613,000 |
|
|
|
1,387,000 |
|
Quarterly
Subtotal
|
|
|
190,600 |
|
|
$ |
2.62 |
|
|
|
190,600 |
|
|
|
1,387,000 |
|
Total
|
|
|
613,000 |
|
|
$ |
2.44 |
|
|
|
613,000 |
|
|
|
1,387,000 |
|
Item
6.
Exhibits
Exhibit
Number
Description
3.1
|
Amended
and Restated Articles of Incorporation. (1)
|
|
|
3.2
|
Articles
of Amendment to the Amended and Restated Articles of Incorporation
of the
Company increasing the number of authorized shares of common stock
to
27,000,000 shares. (2)
|
|
|
3.3
|
Articles
of Amendment to the Amended and Restated Articles of Incorporation
of the
Company increasing the number of authorized shares of common stock
to
35,500,000 shares. (3)
|
|
|
3.4
|
Articles
of Amendment to the Amended and Restated Articles of Incorporation
of the
Company increasing the number of authorized shares of common stock
to
38,500,000 shares. (4)
|
|
|
3.5
|
Amended
and Restated
By-Laws. (5)
|
4.1
|
Amended
and Restated Articles of Incorporation (same as Exhibit
3.1).
|
|
|
4.2
|
Articles
of Amendment to the Amended and Restated Articles of Incorporation
of the
Company (same as Exhibit 3.2).
|
|
|
4.3
|
Articles
of Amendment to the Amended and Restated Articles of Incorporation
of the
Company increasing the number of authorized shares of common stock
to
35,500,000 shares (same as Exhibit 3.3).
|
|
|
4.4
|
Articles
of Amendment to the Amended and Restated Articles of Incorporation
of the
Company increasing the number of authorized shares of common stock
to
38,500,000 shares (same as Exhibit 3.4).
|
|
|
4.5
|
Articles
II, VII and XI of the Amended and Restated By-Laws (included in
Exhibit 3.5).
|
|
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
|
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002.
|
|
|
32.1
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
18
U.S.C. Section 1350 (Section 906 of the Sarbanes-Oxley Act of
2002) (6)
|
_____________________________
(1)
|
Incorporated
herein by reference to the Company's Registration Statement on
Form SB-2, filed with the Securities and Exchange Commission on
October 19, 1999.
|
|
|
(2)
|
Incorporated
by reference to the Company's Registration Statement on Form SB-2,
filed with the Securities and Exchange Commission on September 21,
2000.
|
|
|
(3)
|
Incorporated
by reference to the Company's Registration Statement on Form SB-2,
filed with the Securities and Exchange Commission on September 6,
2002.
|
|
|
(4)
|
Incorporated
by reference to the Company's Quarterly Report on Form 10-QSB for
the
quarter ended December 31, 2003.
|
|
|
(5)
|
Incorporated
herein by reference to the Company's Registration Statement on
Form S-18, as filed with the securities and Exchange Commission on
May 25, 1990.
|
|
|
(6)
|
This
certification is not "filed" for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or incorporated by reference into
any
filing under the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended.
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
THE
FEMALE HEALTH COMPANY
DATE: August
12, 2008
/s/
O.B.Parrish
O.B.
Parrish, Chairman and
Chief
Executive Officer
DATE: August
12, 2008
/s/
Donna
Felch
Donna
Felch, Vice President and Chief
Financial
Officer