e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
AND EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED DECEMBER
31, 2006.
|
|
|
o |
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES AND EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM TO .
Commission File No. 001-31298
LANNETT COMPANY, INC.
(Exact Name of Registrant as Specified in its Charter)
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|
State of Delaware
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23-0787699 |
(State of Incorporation)
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|
(I.R.S. Employer I.D. No.) |
9000 State Road
Philadelphia, PA 19136
(215) 333-9000
(Address of principal executive offices and telephone number)
Indicate by check mark whether the registrant (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 registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes þ No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of
accelerated filer and large accelerated filer in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12B-2 of the Exchange Act).
Yes o No þ
As of January 31, 2007, there were 24,165,325 shares of the issuers common stock, $.001 par value,
outstanding.
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
LANNETT COMPANY, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
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December 31, 2006 |
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June 30, 2006 |
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(unaudited) |
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ASSETS |
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Current Assets |
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|
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Cash |
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$ |
2,006,530 |
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$ |
468,359 |
|
Trade accounts receivable (net of allowance of $250,000 for both periods) |
|
|
27,171,392 |
|
|
|
24,921,671 |
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Inventories |
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|
9,485,026 |
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|
|
11,476,503 |
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Interest receivable |
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|
100,285 |
|
|
|
193,549 |
|
Prepaid taxes |
|
|
2,195,782 |
|
|
|
3,212,511 |
|
Deferred tax assets current portion |
|
|
1,461,172 |
|
|
|
1,461,172 |
|
Other current assets |
|
|
1,771,121 |
|
|
|
1,753,082 |
|
|
|
|
|
|
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|
Total Current Assets |
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|
44,191,308 |
|
|
|
43,486,847 |
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|
|
|
|
|
|
|
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Property, plant, and equipment |
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|
31,015,842 |
|
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28,782,350 |
|
Less accumulated depreciation |
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|
(10,344,231 |
) |
|
|
(9,136,801 |
) |
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|
|
|
|
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20,671,611 |
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19,645,549 |
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Construction in progress |
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|
705,203 |
|
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|
1,955,508 |
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Investment securities available for sale |
|
|
3,771,518 |
|
|
|
5,621,609 |
|
Note receivable |
|
|
8,529,163 |
|
|
|
3,182,498 |
|
Intangible asset (product rights) net of accumulated amortization |
|
|
12,938,835 |
|
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13,831,168 |
|
Deferred tax asset |
|
|
16,324,696 |
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|
18,070,674 |
|
Other assets |
|
|
240,746 |
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|
|
198,211 |
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|
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TOTAL ASSETS |
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$ |
107,373,080 |
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$ |
105,992,064 |
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LIABILITIES AND SHAREHOLDERS EQUITY
LIABILITIES |
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Current Liabilities |
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|
|
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Accounts payable |
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$ |
4,609,938 |
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$ |
763,744 |
|
Accrued expenses |
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|
4,262,256 |
|
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|
5,217,894 |
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Unearned grant funds |
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500,000 |
|
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|
500,000 |
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Current portion of long term debt |
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591,775 |
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|
546,886 |
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Rebates and chargebacks payable |
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8,558,558 |
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13,012,084 |
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Total Current Liabilities |
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18,522,527 |
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20,040,608 |
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|
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Long term debt, less current portion |
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7,349,491 |
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7,649,806 |
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Deferred tax liability |
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|
2,545,734 |
|
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|
2,545,734 |
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|
|
|
|
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TOTAL LIABILITIES |
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|
28,417,752 |
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|
30,236,148 |
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SHAREHOLDERS EQUITY |
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Common stock authorized 50,000,000 shares, par value $0.001;
issued and outstanding, 24,154,749 and 24,141,325 shares, respectively |
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24,154 |
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|
24,141 |
|
Additional paid in capital |
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|
72,318,937 |
|
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|
71,742,402 |
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Retained earnings |
|
|
7,046,053 |
|
|
|
4,456,387 |
|
Accumulated other comprehensive loss |
|
|
(39,246 |
) |
|
|
(72,444 |
) |
|
|
|
|
|
|
|
|
|
|
79,349,898 |
|
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|
76,150,486 |
|
Less: Treasury stock at cost 50,900 shares |
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|
(394,570 |
) |
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|
(394,570 |
) |
|
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|
|
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|
TOTAL SHAREHOLDERS EQUITY |
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|
78,955,328 |
|
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|
75,755,916 |
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|
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
|
$ |
107,373,080 |
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|
$ |
105,992,064 |
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|
The accompanying notes to consolidated financial statements are an integral part of these
statements.
2
LANNETT COMPANY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)
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Three months ended |
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Six months ended |
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December 31, |
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December 31, |
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2006 |
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|
2005 |
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|
2006 |
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|
2005 |
|
Net sales |
|
$ |
22,916,347 |
|
|
$ |
15,228,767 |
|
|
$ |
44,884,171 |
|
|
$ |
28,870,299 |
|
Cost of sales (excluding amortization of
intangible asset) |
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|
17,244,285 |
|
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|
8,063,974 |
|
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|
30,090,680 |
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|
14,926,759 |
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Gross profit |
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5,672,062 |
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|
7,164,793 |
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|
|
14,793,491 |
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|
13,943,540 |
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|
|
|
|
|
|
|
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|
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Research and development expenses |
|
|
1,538,108 |
|
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|
2,420,977 |
|
|
|
3,316,535 |
|
|
|
3,562,077 |
|
Selling, general, & administrative expenses |
|
|
1,961,956 |
|
|
|
2,204,916 |
|
|
|
6,344,458 |
|
|
|
4,782,051 |
|
Amortization of intangible assets |
|
|
446,166 |
|
|
|
446,167 |
|
|
|
892,332 |
|
|
|
892,333 |
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|
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|
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|
|
|
|
|
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Operating income |
|
|
1,725,832 |
|
|
|
2,092,733 |
|
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|
4,240,166 |
|
|
|
4,707,079 |
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Other income (expense): |
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|
|
|
|
|
|
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|
|
|
|
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|
Interest expense |
|
|
(68,369 |
) |
|
|
(85,441 |
) |
|
|
(132,394 |
) |
|
|
(193,444 |
) |
Interest income |
|
|
112,197 |
|
|
|
99,300 |
|
|
|
210,805 |
|
|
|
247,349 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43,828 |
|
|
|
13,859 |
|
|
|
78,411 |
|
|
|
53,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Income before income tax expense |
|
|
1,769,660 |
|
|
|
2,106,592 |
|
|
|
4,318,577 |
|
|
|
4,760,984 |
|
Income tax expense |
|
|
707,864 |
|
|
|
842,518 |
|
|
|
1,728,911 |
|
|
|
1,895,933 |
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|
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|
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Net income |
|
$ |
1,061,796 |
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|
$ |
1,264,074 |
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$ |
2,589,666 |
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$ |
2,865,051 |
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Basic earnings per share |
|
$ |
0.04 |
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|
$ |
0.05 |
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|
$ |
0.11 |
|
|
$ |
0.12 |
|
Diluted earnings per share |
|
$ |
0.04 |
|
|
$ |
0.05 |
|
|
$ |
0.11 |
|
|
$ |
0.12 |
|
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|
|
|
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|
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|
|
|
|
|
|
|
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|
Basic weighted average number of shares |
|
|
24,154,553 |
|
|
|
24,125,884 |
|
|
|
24,151,237 |
|
|
|
24,122,181 |
|
Diluted weighted average number of shares |
|
|
24,222,515 |
|
|
|
24,151,222 |
|
|
|
24,197,946 |
|
|
|
24,140,863 |
|
The accompanying notes to consolidated financial statements are an integral part of these
statements.
3
LANNETT COMPANY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS EQUITY
(UNAUDITED)
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Accumulated Other |
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Total |
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|
Common Stock |
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Additional Paid- |
|
|
Retained |
|
|
Treasury |
|
|
Comprehensive Loss, |
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|
Shareholders' |
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|
Shares |
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Amount |
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|
in Capital |
|
|
Earnings |
|
|
Stock |
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|
net |
|
|
Equity |
|
Balance at June 30, 2006 |
|
|
24,141,325 |
|
|
$ |
24,141 |
|
|
$ |
71,742,402 |
|
|
$ |
4,456,387 |
|
|
|
($394,570 |
) |
|
|
($72,444 |
) |
|
$ |
75,755,916 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued in connection
with employee stock
purchase plan |
|
|
13,424 |
|
|
|
13 |
|
|
|
61,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
61,283 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Compensation expense |
|
|
|
|
|
|
|
|
|
|
515,265 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
515,265 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,198 |
|
|
|
33,198 |
|
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|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Net Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,589,666 |
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|
|
|
|
|
|
|
|
|
|
2,589,666 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
24,154,749 |
|
|
$ |
24,154 |
|
|
$ |
72,318,937 |
|
|
$ |
7,046,053 |
|
|
$ |
(394,570 |
) |
|
$ |
(39,246 |
) |
|
$ |
78,955,328 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
The accompanying notes to consolidated financial statements are an integral part of this
statement.
4
LANNETT COMPANY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
For the six months ended |
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net income |
|
$ |
2,589,666 |
|
|
$ |
2,865,051 |
|
Adjustments to reconcile net income to
net cash provided by (used in) operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
2,183,971 |
|
|
|
1,930,920 |
|
Deferred tax expense |
|
|
1,745,978 |
|
|
|
867,483 |
|
Stock compensation expense |
|
|
515,265 |
|
|
|
685,983 |
|
Gain from sale of asset |
|
|
(8,208 |
) |
|
|
|
|
Changes in assets and liabilities which provided (used) cash: |
|
|
|
|
|
|
|
|
Trade accounts receivable |
|
|
(6,703,247 |
) |
|
|
(8,297,320 |
) |
Inventories |
|
|
1,991,477 |
|
|
|
(901,802 |
) |
Prepaid taxes |
|
|
1,016,729 |
|
|
|
1,000,000 |
|
Prepaid expenses and other assets |
|
|
32,689 |
|
|
|
38,800 |
|
Accounts payable |
|
|
3,846,194 |
|
|
|
259,862 |
|
Accrued expenses |
|
|
(955,636 |
) |
|
|
1,097,888 |
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
6,254,878 |
|
|
|
(453,135 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment (including
construction in progress) |
|
|
(1,069,188 |
) |
|
|
(2,678,847 |
) |
Proceeds from sale of asset |
|
|
10,000 |
|
|
|
|
|
Sales of investment securities available for sale |
|
|
1,883,289 |
|
|
|
2,249,681 |
|
Issuance of note receivable |
|
|
(5,346,665 |
) |
|
|
(2,000,000 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(4,522,564 |
) |
|
|
(2,429,166 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Repayments of debt |
|
|
(255,426 |
) |
|
|
(7,011,182 |
) |
Proceeds from debt, net of restricted cash released |
|
|
|
|
|
|
5,750,000 |
|
Proceeds from issuance of stock |
|
|
61,283 |
|
|
|
65,051 |
|
|
|
|
|
|
|
|
Net cash used in financing activities |
|
|
(194,143 |
) |
|
|
(1,196,131 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE/(DECREASE) IN CASH |
|
|
1,538,171 |
|
|
|
(4,078,432 |
) |
|
|
|
|
|
|
|
|
|
CASH, BEGINNING OF PERIOD |
|
|
468,359 |
|
|
|
4,165,601 |
|
|
|
|
|
|
|
|
CASH, END OF PERIOD |
|
$ |
2,006,530 |
|
|
$ |
87,169 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
75,051 |
|
|
$ |
193,444 |
|
|
|
|
|
|
|
|
Income taxes paid |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
The accompanying notes to consolidated financial statements are an integral part of these
statements.
5
LANNETT COMPANY, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS UNAUDITED
Note 1. Interim Financial Information
The accompanying unaudited financial statements have been prepared in accordance with U.S.
generally accepted accounting principles for presentation of interim financial statements and with
the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, the unaudited
financial statements do not include all the information and footnotes necessary for a comprehensive
presentation of the financial position, results of operations, and cash flows for the periods
presented. In the opinion of management, the unaudited financial statements include all the normal
recurring adjustments that are necessary for a fair presentation of the financial position, results
of operations, and cash flows for the periods presented. Operating results for the three month and
six month periods ended December 31, 2006 are not necessarily indicative of the results that may be
expected for the year ending June 30, 2007. You should read these unaudited financial statements in
combination with the other Notes in this section; Managements Discussion and Analysis of
Financial Condition and Results of Operations appearing in Item 2; and the Financial Statements,
including the Notes to the Financial Statements, included in our Annual Report on Form 10-K for the
year ended June 30, 2006.
Note 2. Summary of Significant Accounting Policies
Lannett Company, Inc., a Delaware Corporation, and subsidiaries (the Company), develop,
manufacture, package, market, and distribute pharmaceutical products sold under generic chemical
names. The Company primarily manufactures solid oral dosage forms, including tablets and capsules,
and is pursuing partnerships and research contracts for the development and production of other
dosage forms, including liquids and injectable products.
Revenue recognition and accounts receivable, adjustments for chargebacks, rebates and returns,
allowance for doubtful accounts and realization of deferred income tax assets represent significant
estimates made by management.
Principles of Consolidation - The consolidated financial statements include the accounts of the
operating parent company, Lannett Company, Inc., and its wholly owned subsidiaries, Lannett
Holdings, Inc. and an inactive subsidiary.
Revenue Recognition - The Company maintains pricing agreements with all customers. Revenue is
recognized at the agreed price upon delivery to the customer, when title and risk of loss have
transferred to the customer, collectibility is reasonably assured and provisions for estimates,
including rebates, promotional adjustments, price adjustments, returns, chargebacks, and other
potential adjustments are reasonably determinable. Accruals for these provisions are presented in
the consolidated financial statements as rebates and chargebacks payable on the balance sheet and
are included in net sales, as reductions, on the statement of income. Net sales, as presented in
the statements of income, are based upon revenue earned upon shipment, less reserves for
chargebacks, rebates, returns and other adjustments to sales.
Chargebacks The chargeback provision is based upon contracted prices with customers, and the
accuracy of this provision is affected by changes in product sales mix and by the length of time it
takes for wholesalers to move the products to the ultimate customers. This is considered the most
significant and complex estimate used in the recognition of revenue.
The chargeback process begins when the Company sells its products through wholesalers to indirect
customers such as independent pharmacies, managed care organizations, hospitals, nursing homes,
and group purchasing organizations. The Company enters into agreements with its indirect customers
to establish pricing for certain
6
products. The indirect customers then select a wholesaler from
which to receive the products at these contractual prices.
Upon the sale of a product to a wholesaler, the Company records the estimated chargeback provision
based upon estimated indirect customers purchases and the contract prices with those indirect
customers. Once the sale to the indirect customer occurs, the wholesaler requests a chargeback
credit from the Company equal to the difference between the contractual price with the indirect
customer and the wholesalers invoice price, if the price sold to the indirect customer is lower
than the direct price to the wholesaler. The provision for chargebacks is based on expected
sell-through levels by the Companys wholesale customers to the indirect customers.
Rebates Rebates are offered to the Companys key customers and buying groups to promote customer
loyalty and encourage product sales. These rebate programs provide customers with rebate credits
upon attainment of pre-established volumes or attainment of net sales milestones for a specified
period. Other promotional programs are incentive programs offered to the customers. At the time
of shipment, the Company estimates reserves for rebates and other promotional credit programs based
on the specific terms in each agreement. The reserve for rebates increases as sales to certain
wholesale and retail customers increase. However, these rebate programs are tailored to the
customers individual programs. Hence, the reserve will depend on the mix of customers that
comprise such rebate programs.
Returns Consistent with industry practice, the Company has a product returns policy that allows
certain customers to return product within a specified period before and after the products lot
expiration date in exchange for a credit to be applied against future purchases. The Companys
policy requires that the customer obtain pre-approval from the Company for any qualifying return.
The Company estimates its provision for returns based on historical experience, business practices,
and credit terms. While such experience has allowed for reasonable estimations in the past,
historical returns may not always be an accurate indicator of future returns. The Company monitors
the provisions for returns and makes adjustments when management believes that actual product
returns may differ from established reserves. Generally, the reserve for returns increases as net
sales increase. The reserve for returns is included in rebates and chargebacks payable on the
balance sheet.
Other Adjustments Other adjustments consist primarily of price adjustments, also known as shelf
stock adjustments, which are credits issued to reflect decreases in the selling prices of the
Companys products that customers have remaining in their inventories at the time of the price
reduction. Decreases in selling prices are discretionary decisions made by management in response
to competitive market conditions. Amounts recorded for estimated shelf stock adjustments are based
upon specified terms with direct customers, expected declines in market prices, and estimates of
inventory held by customers. The Company regularly monitors these and other factors and evaluates
the reserve as additional information becomes available. Other adjustments are included in rebates
and chargebacks payable on the balance sheet.
The following tables identify the reserves for each major category of revenue allowance and a
summary of the activity for the six months ended December 31, 2006 and 2005:
For the six months ended December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Category |
|
Chargebacks |
|
Rebates |
|
Returns |
|
Other |
|
Total |
Reserve balance as of June 30, 2006 |
|
$ |
10,137,400 |
|
|
$ |
2,183,100 |
|
|
$ |
416,000 |
|
|
$ |
275,600 |
|
|
$ |
13,012,100 |
|
Actual credits issued related to sales
recorded in prior fiscal years |
|
|
(10,120,000 |
) |
|
|
(1,702,800 |
) |
|
|
(869,500 |
) |
|
|
(219,000 |
) |
|
|
(12,911,300 |
) |
Reserves or (reversals) charged during
Fiscal 2007 related to sales recorded
in prior fiscal years |
|
|
|
|
|
|
(300,000 |
) |
|
|
460,000 |
|
|
|
|
|
|
|
160,000 |
|
Reserves charged to net sales during
fiscal 2007 related to sales recorded
in fiscal 2007 |
|
|
15,851,400 |
|
|
|
5,750,100 |
|
|
|
590,000 |
|
|
|
350,000 |
|
|
|
22,541,500 |
|
Actual credits issued related to sales
recorded in Fiscal 2007 |
|
|
(10,065,500 |
) |
|
|
(3,808,500 |
) |
|
|
(254,700 |
) |
|
|
(115,000 |
) |
|
|
(14,243,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Reserve balance as of December 31, 2006 |
|
$ |
5,803,300 |
|
|
$ |
2,121,900 |
|
|
$ |
341,800 |
|
|
$ |
291,600 |
|
|
$ |
8,558,600 |
|
7
For the six months ended December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Category |
|
Chargebacks |
|
Rebates |
|
Returns |
|
Other |
|
Total |
Reserve Balance as of June 30, 2005 |
|
$ |
7,999,700 |
|
|
$ |
1,028,800 |
|
|
$ |
1,692,000 |
|
|
$ |
29,500 |
|
|
$ |
10,750,000 |
|
Actual credits issued related to sales
recorded in prior fiscal years |
|
|
(7,100,000 |
) |
|
|
(950,000 |
) |
|
|
(1,450,000 |
) |
|
|
(29,500 |
) |
|
|
(9,529,500 |
) |
Reserves or (reversals) charged during
Fiscal 2006 related to sales recorded
in prior fiscal years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserves charged to net sales during
fiscal 2006 related to sales recorded
in fiscal 2006 |
|
|
10,756,100 |
|
|
|
2,697,600 |
|
|
|
602,900 |
|
|
|
470,300 |
|
|
|
14,526,900 |
|
Actual credits issued related to sales
recorded in Fiscal 2006 |
|
|
(3,674,300 |
) |
|
|
(2,487,100 |
) |
|
|
(129,400 |
) |
|
|
(382,300 |
) |
|
|
(6,673,100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Balance as of December 31, 2005 |
|
$ |
7,981,500 |
|
|
$ |
289,300 |
|
|
$ |
715,500 |
|
|
$ |
88,000 |
|
|
$ |
9,074,300 |
|
Please see the discussion regarding the above tables in Managements Discussion and Analysis.
Accounts Receivable - The Company continuously monitors collections and payments from its customers
and maintains a provision for estimated credit losses based upon historical experience and any
specific customer collection issues that have been identified. This provision is $250,000 at
December 31, 2006 and June 30, 2006.
Fair Value of Financial Instruments - The Companys financial instruments consist primarily of cash
and cash equivalents, trade receivables, trade payables and debt instruments. The carrying values
of cash and cash equivalents, trade receivables, and trade payables are considered to be
representative of their respective fair values. The Companys debt instruments are fixed rate,
with a lower interest rate than the prevailing market rates. The Company has been able to obtain
favorable rates through Philadelphia and Pennsylvania Industrial Development Authorities.
Deferred Debt Acquisition Costs - Costs incurred in connection with obtaining financing are
amortized by the straight-line method over the term of the loan arrangements. These costs are
included in interest expense in the Consolidated Statements of Income. Amortization expense for
debt acquisition costs for the three months ended December 31, 2006 and 2005 was approximately
$9,000 and $ 36,000, respectively, and for the six months ended December 31, 2006 and 2005 was
approximately $18,000 and $ 42,000, respectively
Shipping and Handling Costs The cost of shipping products to customers is recognized at the time
the products are shipped, and is included in Cost of Sales.
Research and Development Research and development expenses are charged to operations as incurred.
Advertising Costs - The Company charges advertising costs to operations as incurred.
Segment Information The Company reports segment information in accordance with Statement of
Financial Accounting Standard No. 131 (FAS 131), Disclosures about Segments of an Enterprise and
Related
Information. The Company operates one business segment generic pharmaceuticals and one
reporting segment. In accordance with FAS 131, the Company aggregates its financial information
for all products and reports on one operating segment. The Companys products contain various
active pharmaceutical ingredients aimed at treating a diverse range of medical indications. The
following table identifies the Companys approximate net product sales by medical indication for
the three and six months ended December 31, 2006 and 2005:
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
For the Six Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
Medical Indication |
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Migraine Headache |
|
$ |
2,671,000 |
|
|
$ |
3,346,000 |
|
|
$ |
5,162,000 |
|
|
$ |
6,519,000 |
|
Epilepsy |
|
|
1,815,000 |
|
|
|
3,329,000 |
|
|
|
4,473,000 |
|
|
|
6,689,000 |
|
Heart Failure |
|
|
1,000,000 |
|
|
|
1,518,000 |
|
|
|
2,503,000 |
|
|
|
3,266,000 |
|
Thyroid Deficiency |
|
|
12,118,000 |
|
|
|
3,411,000 |
|
|
|
18,278,000 |
|
|
|
7,280,000 |
|
Antibacterial |
|
|
4,428,000 |
|
|
|
1,598,000 |
|
|
|
12,090,000 |
|
|
|
2,036,000 |
|
Other |
|
|
884,000 |
|
|
|
2,027,000 |
|
|
|
2,378,000 |
|
|
|
3,080,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
22,916,000 |
|
|
$ |
15,229,000 |
|
|
$ |
44,884,000 |
|
|
$ |
28,870,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Options In December 2004, the Financial Accounting Standards Board (FASB) issued Statement
of Financial Accounting Standards (SFAS) No. 123 (R), Share-Based Payment (SFAS 123(R)). This
standard is a revision of SFAS 123, Accounting for Stock-Based Compensation and supersedes
Accounting Principles Board Opinion (APB) No. 25, Accounting for Stock Issued to Employees.
SFAS 123(R) addresses the accounting for share-based compensation in which we receive employee
services in exchange for our equity instruments. Under the standard, we are required to recognize
compensation cost for share-based compensation issued to or purchased by employees, net of
estimated forfeitures, under share-based compensation plans using a fair value method.
At December 31, 2006, the Company had two stock-based employee compensation plans. Prior to July
1, 2005, the Company accounted for those plans under the recognition and measurement provisions of
APB 25, and related Interpretations, as permitted by SFAS 123. Effective July 1, 2005, the Company
adopted the fair value recognition provisions of SFAS 123(R), using the
modified-prospective-transition method.
Accordingly, prior periods have not been restated. Under this method, the Company is required to
record compensation expense for all awards granted after the date of adoption and for the unvested
portion of previously granted awards that remained outstanding as of the beginning of the period of
adoption. The Company measures share-based compensation cost using the Black-Scholes option
pricing model. The following table presents the weighted average assumptions used to estimate fair
values of the stock options granted during the six months ended December 31, 2006:
|
|
|
|
|
Risk-free interest rate |
|
|
4.74 |
% |
Expected volatility |
|
|
59 |
% |
Expected dividend yield |
|
|
0.0 |
% |
Expected term (in years) |
|
|
5.00 |
|
There were approximately 220,000 and 354,000 options issued during the three and six months
ended December 31, 2006. This compares to approximately 20,000 options issued during the three and
six months ended December 31, 2005. 375 shares under option were exercised in the three and six
months ended December 31, 2006, resulting in proceeds of $281 to the Company. There were no
exercises in the three and six month periods ended December 31, 2005.
Expected volatility is based on the historical volatility of the price of our common shares since
active trading commenced on the American Stock Exchange in April 2002. We use historical
information to estimate expected term within the valuation model. The expected term of awards
represents the period of time that options granted are expected to be outstanding. The risk-free
rate for periods within the expected life of the option is based on the U.S. Treasury yield curve
in effect at the time of grant. Compensation cost is recognized using a straight-line method over
the vesting or service period and is net of estimated forfeitures.
9
The forfeiture rate assumption is the estimated annual rate at which unvested awards are expected
to be forfeited during the vesting period. This assumption is based on our historical forfeiture
rate. Periodically, management will assess whether it is necessary to adjust the estimated rate to
reflect changes in actual forfeitures or changes in expectations. For example, adjustments may be
needed if, historically, forfeitures were affected mainly by turnover that resulted from a business
restructuring that is not expected to recur. The increase in the forfeiture rate from 3% at
December 31, 2005 to 5.0% at December 31, 2006 is an adjustment made to account for recent turnover
at manager levels. As the Company continues to grow, this rate is likely to change to match such
changes in growth businesses. Under the provisions of FAS 123R, the Company will incur additional
expense if the actual forfeiture rate is lower than originally estimated. A recovery of prior
expense will be recorded if the actual rate is higher than originally estimated.
The following table presents all share-based compensation costs recognized in our statements of
income as part of selling, general and administrative expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Method used to account for share-based compensation |
|
Fair Value |
|
Fair Value |
|
Fair Value |
|
Fair Value |
Share-based compensation under SFAS 123(R) |
|
$ |
258,248 |
|
|
$ |
359,301 |
|
|
$ |
515,265 |
|
|
$ |
685,983 |
|
Tax benefit |
|
$ |
46,940 |
|
|
$ |
79,350 |
|
|
$ |
93,881 |
|
|
$ |
158,700 |
|
Options outstanding that have vested and are expected to vest as of December 31, 2006 are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
Aggregate |
|
Average |
|
|
|
|
|
|
Exercise |
|
Intrinsic |
|
Remaining |
|
|
Awards |
|
Price |
|
Value |
|
Contractual Life |
Vested |
|
|
564,375 |
|
|
$ |
11.54 |
|
|
$ |
85,274 |
|
|
|
6.7 |
|
Expected to vest |
|
|
546,550 |
|
|
$ |
7.26 |
|
|
$ |
263,223 |
|
|
|
9.2 |
|
Total |
|
|
1,110,925 |
|
|
$ |
9.38 |
|
|
$ |
348,497 |
|
|
|
7.9 |
|
A summary of award activity under the Plans as of December 31, 2006 and 2005, and changes
during the six months then ended, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
Aggregate |
|
Average |
|
|
|
|
|
|
Exercise |
|
Intrinsic |
|
Remaining |
|
|
Awards |
|
Price |
|
Value |
|
Contractual Life |
Outstanding at July 1, 2006 |
|
|
792,003 |
|
|
$ |
10.89 |
|
|
|
|
|
|
|
7.3 |
|
Granted |
|
|
353,783 |
|
|
$ |
6.02 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
375 |
|
|
|
0.75 |
|
|
$ |
2,063 |
|
|
|
|
|
Forfeited or expired |
|
|
5,720 |
|
|
|
10.73 |
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2006 |
|
|
1,139,691 |
|
|
$ |
9.38 |
|
|
$ |
362,351 |
|
|
|
7.9 |
|
Outstanding at December 31,
2006 and not yet vested |
|
|
575,316 |
|
|
$ |
7.26 |
|
|
$ |
277,076 |
|
|
|
9.2 |
|
Exercisable at December 31, 2006 |
|
|
564,375 |
|
|
$ |
11.54 |
|
|
$ |
85,274 |
|
|
|
6.7 |
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
Aggregate |
|
Average |
|
|
|
|
|
|
Exercise |
|
Intrinsic |
|
Remaining |
|
|
Awards |
|
Price |
|
Value |
|
Contractual Life |
Outstanding at July 1, 2005 |
|
|
857,108 |
|
|
$ |
13.72 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
83,500 |
|
|
$ |
5.18 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2005 |
|
|
940,608 |
|
|
$ |
11.33 |
|
|
$ |
340,320 |
|
|
|
8.2 |
|
Outstanding at December 31,
2005 and not yet vested |
|
|
418,527 |
|
|
$ |
11.17 |
|
|
$ |
245,110 |
|
|
|
8.4 |
|
Exercisable at December 31, 2005 |
|
|
522,081 |
|
|
$ |
11.45 |
|
|
$ |
95,210 |
|
|
|
7.8 |
|
As of December 31, 2006, there was approximately $2,111,000 of total unrecognized compensation
cost related to nonvested share-based compensation awards granted under the Plans. That cost is
expected to be recognized over a weighted average period of 1.7 years. As of December 31, 2005,
there was approximately $1,806,000 of total unrecognized compensation cost related to nonvested
share-based compensation awards granted under the Plans.
Unearned Grant Funds The Company records all grant funds received as a liability until the
Company fulfills all the requirements of the grant funding program.
Note 3. New Accounting Standards
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections a
replacement of APB Opinion No. 20 and FASB Statement No. 3 (SFAS No. 154), which replaces APB
Opinion No. 20, Accounting Changes, and SFAS No. 3, Reporting Accounting Changes in Interim
Financial Statements, and changes the requirements for the accounting for and reporting of a
change in accounting principle. SFAS No. 154 requires companies to recognize a change in accounting
principle retrospectively in prior period financial statements. This applies to all voluntary
changes in accounting principle, and also applies to changes required by an accounting
pronouncement in the unusual instance that the pronouncement does not include specific transition
provisions. SFAS No. 154 is effective for accounting changes and corrections of errors made in
fiscal years beginning after December 15, 2005, which, in the Companys case, is the current fiscal
year beginning July 1, 2006. SFAS No. 154 does not change the transition provisions of any existing
accounting pronouncements, including those that are in a transition phase as of the effective date
of SFAS No. 154. The adoption of this standard did not have a material impact on our financial
statements.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). This
Statement defines fair value, establishes a framework for measuring fair value in generally
accepted accounting principles (GAAP), and expands disclosures about fair value measurements. This
Statement applies under other accounting pronouncements that require or permit fair value
measurements, the Board having previously concluded in those accounting pronouncements that fair
value is the relevant measurement attribute. Accordingly, this Statement does not require any new
fair value measurements. However, for some entities, the application of this Statement will change
current practice. This Statement is effective for financial statements issued for fiscal years
beginning after November 15, 2007, and interim periods within those fiscal years. The Company will
be required to adopt the guidance of SFAS 107 beginning July 1, 2008. The Company has not
completed its study of the effects of adopting this standard.
In July 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxes
(FIN 48), to clarify the accounting for uncertainty in income taxes recognized in an enterprises
financial statements in accordance with SFAS 109, Accounting for Income Taxes. Effective for
fiscal years beginning after December 15, 2006, 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. The Company will be required to adopt the guidance
of FIN 48 beginning July 1, 2007. While earlier adoption is permitted by the FASB, the Company has
not yet completed its evaluation of the impact that adoption of FIN 48 will have on its financial
statements.
11
In September 2006, the SEC staff issued Staff Accounting Bulletin No. 108, Considering the Effects
of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements.
SAB 108 was issued to provide consistency between how registrants quantify financial statement
misstatements.
Historically, there have been two widely-used methods for quantifying the effects of financial
statement misstatements. These methods are referred to as the roll-over and iron curtain
method. The roll-over method quantifies the amount by which the current year income statement is
misstated. Exclusive reliance on an income statement approach can result in the accumulation of
errors on the balance sheet that may not have been material to any individual income statement, but
which may misstate one or more balance sheet accounts. The iron curtain method quantifies the
error as the cumulative amount by which the current year balance sheet is misstated. Exclusive
reliance on a balance sheet approach can result in disregarding the effects of errors in the
current year income statement that results from the correction of an error existing in previously
issued financial statements. We currently use the roll-over method for quantifying identified
financial statement misstatements.
SAB 108 established an approach that requires quantification of financial statement misstatements
based on the effects of the misstatement on each of the Companys financial statements and the
related financial statement disclosures. This approach is commonly referred to as the dual
approach because it requires quantification of errors under both the roll-over and iron curtain
methods.
SAB 108 allows registrants to initially apply the dual approach either by (1) retroactively
adjusting prior financial statements as if the dual approach had always been used or by (2)
recording the cumulative effect of initially applying the dual approach as adjustments to the
carrying values of assets and liabilities as of July 1, 2006 with an offsetting adjustment recorded
to the opening balance of retained earnings. Use of this cumulative effect transition method
requires detailed disclosure of the nature and amount of each individual error being corrected
through the cumulative adjustment and how and when it arose.
The effective date for SAB 108 is the first fiscal year ending after November 15, 2006. For
Lannett, SAB 108 is effective immediately, for the fiscal year ending June 30, 2007. The Company
has not yet determined the effect of adopting this guidance, but will be completing an analysis on
the effect of this guidance before the end of the fiscal year.
Note 4. Inventories
The Company values its inventories at the lower of cost (determined by the first-in, first-out
method) or market, regularly reviews inventory quantities on hand, and records a provision for
excess and obsolete inventory based primarily on estimated forecasts of product demand and
production requirements. Inventories consist of:
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
June 30, 2006 |
|
Raw material |
|
$ |
3,938,383 |
|
|
$ |
5,143,714 |
|
Work-in-process |
|
|
1,517,984 |
|
|
|
1,438,794 |
|
Finished goods |
|
|
3,631,856 |
|
|
|
4,511,274 |
|
Packaging supplies |
|
|
396,803 |
|
|
|
382,721 |
|
|
|
|
|
|
|
|
|
|
$ |
9,485,026 |
|
|
$ |
11,476,503 |
|
|
|
|
|
|
|
|
The preceding amounts are net of inventory reserves of $1,306,830 and $1,054,498 at December 31,
2006 and June 30, 2006, respectively.
Note 5. Property, Plant and Equipment
Property, plant and equipment are stated at cost. Depreciation is provided for by the
straight-line and accelerated methods over estimated useful lives of the assets. Depreciation
expense for the three months ended December 31, 2006 and 2005 was approximately $658,000 and
$530,000, respectively. Depreciation expense for the six months ended December 31, 2006 and 2005
was approximately $1,292,000 and $1,039,000, respectively. Property, plant and equipment consist
of the following:
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
June 30, |
|
|
|
Useful Lives |
|
|
2006 |
|
|
2006 |
|
Land |
|
|
|
|
|
$ |
233,414 |
|
|
$ |
233,414 |
|
Building and improvements |
|
10 - 39 years |
|
|
11,974,573 |
|
|
|
10,612,954 |
|
Machinery and equipment |
|
5 - 10 years |
|
|
17,981,152 |
|
|
|
17,109,279 |
|
Furniture and fixtures |
|
5 - 7 years |
|
|
826,703 |
|
|
|
826,703 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
31,015,842 |
|
|
$ |
28,782,350 |
|
|
|
|
|
|
|
|
|
|
|
|
Note 6. Investment Securities Available-for-Sale
The Companys investment securities consist of marketable debt securities, primarily in U.S.
government and agency obligations, and a $500,000 equity investment in an Active Pharmaceutical
Ingredient (API) provider. All of the Companys marketable debt securities are classified as
available-for-sale and recorded at fair value, based on quoted market prices. The Company accounts
for its investment in the API provider at cost. Unrealized holding gains and losses are recorded,
net of any tax effect, as a separate component of accumulated other comprehensive income. No gains
or losses on marketable debt securities are realized until they are sold or a decline in fair value
is determined to be other-than-temporary. If a decline in fair value is determined to be
other-than-temporary, an impairment charge is recorded and a new cost basis in the investment is
established. There were no securities determined by management to be other-than-temporarily
impaired for the six month period ended December 31, 2006.
The amortized cost, gross unrealized gains and losses, and fair value of the Companys
available-for-sale securities are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
Available-for-Sale |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
Other Investments |
|
$ |
500,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
500,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government Agency |
|
|
2,776,470 |
|
|
|
5,992 |
|
|
|
(53,883 |
) |
|
|
2,728,579 |
|
Mortgage-Backed Securities |
|
|
288,424 |
|
|
|
|
|
|
|
(20,279 |
) |
|
|
268,145 |
|
Asset-Backed Securities |
|
|
272,034 |
|
|
|
6,063 |
|
|
|
(3,303 |
) |
|
|
274,794 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,836,928 |
|
|
$ |
12,055 |
|
|
$ |
(77,465 |
) |
|
$ |
3,771,518 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2006 |
|
Available-for-Sale |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
Other Investments |
|
$ |
500,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
500,000 |
|
U.S. Government Agency |
|
|
4,086,248 |
|
|
|
78 |
|
|
|
(92,221 |
) |
|
|
3,994,105 |
|
Mortgage-Backed Securities |
|
|
312,904 |
|
|
|
|
|
|
|
(20,916 |
) |
|
|
291,988 |
|
Asset-Backed Securities |
|
|
843,197 |
|
|
|
|
|
|
|
(7,681 |
) |
|
|
835,516 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,742,349 |
|
|
$ |
78 |
|
|
$ |
(120,818 |
) |
|
$ |
5,621,609 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The amortized cost and fair value of the Companys current available-for-sale securities by
contractual maturity at December 31, 2006 are summarized as follows:
13
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
|
Available for Sale |
|
|
|
Amortized |
|
|
Fair |
|
|
|
Cost |
|
|
Value |
|
Due in one year or less |
|
$ |
201,540 |
|
|
$ |
197,750 |
|
Due after one year through five years |
|
|
2,610,671 |
|
|
|
2,596,617 |
|
Due after five years through ten years |
|
|
134,819 |
|
|
|
130,626 |
|
Due after ten years |
|
|
889,898 |
|
|
|
846,525 |
|
|
|
|
|
|
|
|
|
|
$ |
3,836,928 |
|
|
$ |
3,771,518 |
|
|
|
|
|
|
|
|
The Company uses the specific identification method to determine the cost of securities sold.
There were no securities held from a single issuer that represented more than 15% of shareholders
equity.
The table below indicates the length of time individual securities have been in a continuous
unrealized loss position as of December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2006 |
|
|
|
|
|
|
|
Less than 12 months |
|
|
12 months or longer |
|
|
Total |
|
Description of |
|
Number of |
|
|
Fair |
|
|
Unrealized |
|
|
Fair |
|
|
Unrealized |
|
|
Fair |
|
|
Unrealized |
|
Securities |
|
Securities |
|
|
Value |
|
|
Loss |
|
|
Value |
|
|
Loss |
|
|
Value |
|
|
Loss |
|
U.S. Government Agency |
|
|
25 |
|
|
|
603,846 |
|
|
|
(4,848 |
) |
|
|
1,174,894 |
|
|
|
(49,035 |
) |
|
|
1,778,740 |
|
|
|
(53,883 |
) |
Mortgage-Backed Securities |
|
|
3 |
|
|
|
120,082 |
|
|
|
(4,032 |
) |
|
|
148,063 |
|
|
|
(16,247 |
) |
|
|
268,145 |
|
|
|
(20,279 |
) |
Asset-Backed Securities |
|
|
3 |
|
|
|
81,863 |
|
|
|
(1,380 |
) |
|
|
118,346 |
|
|
|
(1,923 |
) |
|
|
200,209 |
|
|
|
(3,303 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total temporarily
impaired investment
securities
|
|
|
31 |
|
|
$ |
805,791 |
|
|
$ |
(10,260 |
) |
|
$ |
1,441,303 |
|
|
$ |
(67,205 |
) |
|
$ |
2,247,094 |
|
|
$ |
(77,465 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The investment securities shown above currently have fair values less than amortized cost and
therefore contain unrealized losses. The Company has evaluated these securities and has determined
that the decline in value is not related to any company or industry specific event. At December 31,
2006, there were approximately 31 out of 45 investment securities with unrealized losses. The
Company anticipates full recovery of amortized costs with respect to these securities at maturity
or sooner in the event of a more favorable market interest rate environment. Realized gains and
losses from sale of investment securities have been immaterial for the three and six month periods
ended December 31, 2006 and 2005.
Note 7. Note Receivable
A loan agreement with an API provider (the Borrower) was entered in July 2005. In the agreement,
the Company loaned the Borrower $2,000,000 to finance general business activities. Additional
loans have been made to the Borrower since the loan was initiated. The current balance owed by the
Borrower is approximately $8.5 million. The note receivable is backed by a promissory note and a
security interest in substantially all the Borrowers assets. Interest on the principal balance
will be earned at 10% per annum for the first three years, and then at variable rates based on the
Prime Rate plus 500 basis points. The agreement calls for the Borrower to pay all interest that
has accrued and is due and owing on the Loan on the first, second and third anniversary date of
this Agreement. The borrower requested an extension to the first interest payment, which was due
in July 2006. The borrower subsequently made this interest payment in January 2007. The Borrower
shall pay the principal balance on the loan, plus accrued interest, in twenty four equal
consecutive monthly installments beginning July 2008. Management currently believes this loan is
fully collectible, In the event of a default on the loan, the Company would be able to liquidate
the net assets of the Borrower. However, there is no guarantee that the net assets of the Borrower
will be sufficient to allow the full repayment of the existing loan. In the event that some or the
entire loan is deemed uncollectible, a reserve will be established to recognize the amount
considered uncollectible.
14
Note 8. Bank Line of Credit
The Company has a $3,000,000 line of credit from Wachovia Bank, N.A. that bears interest at the
prime interest rate less 0.25% (8.0% at December 31, 2006). The line of credit was renewed and
extended to November 30, 2007. At December 31, 2006 and 2005, the Company had $0 outstanding under
the line of credit. The line of credit is collateralized by substantially all of the Companys
assets. The Company currently has no plans to borrow under this line of credit.
Note 9. Unearned Grant Funds
In July 2004, the Company received $500,000 of grant funding from the Commonwealth of Pennsylvania,
acting through the Department of Community and Economic Development. The grant funding program
requires the Company to use the funds for machinery and equipment located at their Pennsylvania
locations, hire an additional 100 full-time employees by June 30, 2006, operate its Pennsylvania
locations a minimum of five years and meet certain matching investment requirements. If the
Company fails to comply with any of the requirements above, the Company would be liable to repay
the full amount of the grant funding ($500,000). The Company records the unearned grant funds as a
liability until the Company complies with all of the requirements of the grant funding program. On
a quarterly basis, the Company will monitor its progress in fulfilling the requirements of the
grant funding program and will determine the status of the liability. As of December 31, 2006, the
grant funding is recognized as a short term liability under the caption of Unearned Grant Funds,
since the Company has not yet met the requirement to add 100 full-time employees. However, the
Company is requesting an extension of this obligation to add 100 employees, since the other
requirement related to use of funds has been met already, and the requirement to operate its
Pennsylvania locations is still ongoing.
Note 10. Long-Term Debt
Long-term debt consists of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
June 30, |
|
|
|
2006 |
|
|
2006 |
|
PIDC Regional Development Center, LP III loan |
|
$ |
4,500,000 |
|
|
$ |
4,500,000 |
|
Pennsylvania Industrial Development Authority loan |
|
|
1,205,000 |
|
|
|
1,222,000 |
|
Pennsylvania Department of Community & Economic
Development loan |
|
|
453,000 |
|
|
|
476,000 |
|
Tax-exempt bond loan (PAID) |
|
|
901,000 |
|
|
|
956,000 |
|
Equipment loan |
|
|
882,000 |
|
|
|
1,043,000 |
|
|
|
|
|
|
|
|
Total debt |
|
|
7,941,000 |
|
|
|
8,197,000 |
|
Less current portion |
|
|
592,000 |
|
|
|
547,000 |
|
|
|
|
|
|
|
|
Long term debt |
|
$ |
7,349,000 |
|
|
$ |
7,650,000 |
|
|
|
|
|
|
|
|
On December 13, 2005, the Company refinanced $5,750,000 of its debt through the Philadelphia
Industrial Development Corporation (PIDC) and the Pennsylvania Industrial Development Authority
(PIDA). With the proceeds from the refinancing, the Company paid off its Mortgage and Construction
Loan, as well as a portion of the Equipment loan. These loans were with Wachovia Bank. The
Company financed $4,500,000 through the Immigrant Investor Program (PIDC Regional Center, LP III).
The Company will pay a bi-annual interest payment at a rate equal to two and one-half percent per
annum. The outstanding principal balance shall be due and payable 5 years (60 months) from January
1, 2006. The remaining $1,250,000 is financed through the PIDA
15
Loan. The Company is required to
make equal payments each month for 180 months starting February 1, 2006 with interest of two and
three-quarter percent per annum. The PIDA Loan has $1,204,706 outstanding as of December 31, 2006,
and $87,127 is currently due; none of the PIDC Loan is currently due.
An additional $500,000 was financed through the Pennsylvania Department of Community and Economic
Development Machinery and Equipment Loan Fund. The Company is required to make equal payments for
60 months starting May 1, 2006 with interest of 2.75% per annum. As of December 31, 2006, $453,051
is outstanding, and $119,961 is currently due.
In April 1999, the Company entered into a loan agreement (the Agreement) with a governmental
authority, the Philadelphia Authority for Industrial Development (the Authority or PAID), to
finance future construction and growth projects of the Company. The Authority issued $3,700,000 in
tax-exempt variable rate demand and fixed rate revenue bonds to provide the funds to finance such
growth projects pursuant to a trust indenture (the Trust Indenture). A portion of the Companys
proceeds from the bonds was used to pay for bond issuance costs of approximately $170,000. The
Trust Indenture requires that the Company repay the Authority loan through installment payments
beginning in May 2003 and continuing through May 2014, the year the bonds mature. The bonds bear
interest at the floating variable rate determined by the organization responsible for selling the
bonds (the remarketing agent). The interest rate fluctuates on a weekly basis. The effective
interest rate at December 31, 2006 was 4.1%. At December 31, 2006, the Company has $900,983
outstanding on the Authority loan, of which $64,167 is classified as currently due. The remainder
is classified as a long-term liability. In April 1999, an irrevocable letter of credit of
$3,770,000 was issued by Wachovia Bank, National Association (Wachovia) to secure payment of the
Authority Loan and a portion of the related accrued interest. At December 31, 2006, no portion of
the letter of credit has been utilized.
The Equipment Loan consists of a term loan with a maturity of five years. The Company, as part of
the 2003 Loan Financing agreement with Wachovia, is required to make equal payments of principal
and interest. As of
December 31, 2006, the Company has outstanding $882,526 under the Equipment Loan, of which $320,520
is classified as currently due.
The financing facilities under the 2003 Loan Financing, of which only the Equipment Loan is left,
bear interest at a variable rate equal to the LIBOR rate plus 150 basis points. The LIBOR rate is
the rate per annum, based on a 30-day interest period, quoted two business days prior to the first
day of such interest period for the offering by leading banks in the London interbank market of
dollar deposits. As of December 31, 2006, the interest rate for the 2003 Loan Financing (of which
only the Equipment loan remains) was 6.85%.
The Company has executed Security Agreements with Wachovia, PIDA and PIDC in which the Company has
agreed to pledge substantially all of its assets to collateralize the amounts due.
The terms of the Equipment loan require that the Company meet certain financial covenants and
reporting standards, including the attainment of standard financial liquidity and net worth ratios.
As of December 31, 2006, the Company has complied with such terms, and successfully met its
financial covenants.
Long-term debt amounts due, for the twelve month periods ended December 31 are as follows:
|
|
|
|
|
12 month period ended |
|
Amounts Payable |
|
December 31, |
|
to Institutions |
|
2007 |
|
|
592,000 |
|
2008 |
|
|
604,000 |
|
2009 |
|
|
538,000 |
|
2010 |
|
|
4,808,000 |
|
2011 |
|
|
343,000 |
|
Thereafter |
|
|
1,056,000 |
|
|
|
|
|
|
|
$ |
7,941,000 |
|
|
|
|
|
16
Note 11. Income Taxes
The Company uses the liability method specified by Statement of Financial Accounting Standards No.
109 (FAS 109), Accounting for Income Taxes. Deferred tax assets and liabilities are determined
based on the difference between the financial statement and tax bases of assets and liabilities as
measured by the enacted tax rates which will be in effect when these differences reverse. Deferred
tax expense is the result of changes in deferred tax assets and liabilities.
The provision for federal, state and local income taxes for the three month period ended December
31, 2006 and 2005 was $708,000 and $843,000, respectively, with effective tax rates of 40% and 40%,
respectively. The provision for federal, state and local income taxes for the six month period
ended December 31, 2006 and 2005 was $1,729,000 and $1,896,000, respectively, with effective tax
rates of 40% and 40%, respectively.
Note 12. Earnings Per Share
Statement of Financial Accounting Standards No. 128 (FAS 128), Earnings Per Share, requires the
presentation of basic and diluted earnings per share on the face of the Companys consolidated
statement of income and a reconciliation of the computation of basic earnings per share to diluted
earnings per share. Basic earnings per share excludes the dilutive impact of common stock
equivalents and is computed by dividing net income by the weighted-average number of shares of
common stock outstanding for the period. Diluted earnings per share
includes the effect of potential dilution from the exercise of outstanding common stock equivalents
into common stock using the treasury stock method. Earnings per share amounts for all periods
presented have been calculated in accordance with the requirements of FAS 128. A reconciliation of
the Companys basic and diluted earnings per share follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
Net Income |
|
|
Shares |
|
|
Net Income |
|
|
Shares |
|
|
|
(Numerator) |
|
|
(Denominator) |
|
|
(Numerator) |
|
|
(Denominator) |
|
Basic earnings per share factors |
|
$ |
1,061,796 |
|
|
|
24,154,533 |
|
|
$ |
1,264,850 |
|
|
|
24,125,884 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive stock options |
|
|
|
|
|
|
67,982 |
|
|
|
|
|
|
|
25,338 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share factors |
|
$ |
1,061,796 |
|
|
|
24,222,515 |
|
|
$ |
1,264,850 |
|
|
|
24,151,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share |
|
$ |
0.04 |
|
|
|
|
|
|
$ |
0.05 |
|
|
|
|
|
Diluted earnings per share |
|
$ |
0.04 |
|
|
|
|
|
|
$ |
0.05 |
|
|
|
|
|
The number of anti-dilutive weighted average shares that have been excluded in the computation
of diluted earnings per share for the three months ended December 31, 2006 and 2005 were 869,804
and 871,428, respectively.
17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
Net Income |
|
|
Shares |
|
|
Net Income |
|
|
Shares |
|
|
|
(Numerator) |
|
|
(Denominator) |
|
|
(Numerator) |
|
|
(Denominator) |
|
Basic earnings per share factors |
|
$ |
2,589,666 |
|
|
|
24,151,237 |
|
|
$ |
2,865,051 |
|
|
|
24,122,181 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive stock options |
|
|
|
|
|
|
43,448 |
|
|
|
|
|
|
|
45,590 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share factors |
|
$ |
2,589,666 |
|
|
|
24,194,685 |
|
|
$ |
2,865,051 |
|
|
|
24,167,771 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share |
|
$ |
0.11 |
|
|
|
|
|
|
$ |
0.12 |
|
|
|
|
|
Diluted earnings per share |
|
$ |
0.11 |
|
|
|
|
|
|
$ |
0.12 |
|
|
|
|
|
The number of anti-dilutive weighted average shares that have been excluded in the computation
of diluted earnings per share for the six months ended December 31, 2006 and 2005 were 869,804 and
871,428, respectively.
Note 13. Comprehensive Income
The Companys other comprehensive loss is comprised of unrealized losses on investment securities
classified as available-for-sale. The components of comprehensive income and related taxes
consisted of the following as of December 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
For the Six Months Ended |
|
|
|
12/31/2006 |
|
|
12/31/2005 |
|
|
12/31/2006 |
|
|
12/31/2005 |
|
Other Comprehensive Income (Loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized Holding Gain (Loss) on Securities |
|
$ |
4,615 |
|
|
$ |
(12,402 |
) |
|
$ |
55,330 |
|
|
$ |
(81,688 |
) |
Tax at effective rate |
|
|
(1,846 |
) |
|
|
4,961 |
|
|
|
(22,132 |
) |
|
|
32,675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Unrealized Gain (Loss) on Securities, Net |
|
|
2,769 |
|
|
|
(7,441 |
) |
|
|
33,198 |
|
|
|
(49,013 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other Comprehensive Income (Loss) |
|
|
2,769 |
|
|
|
(7,441 |
) |
|
|
33,198 |
|
|
|
(49,013 |
) |
Net Income |
|
|
1,061,796 |
|
|
|
1,264,074 |
|
|
|
2,589,666 |
|
|
|
2,865,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Comprehensive Income |
|
$ |
1,064,565 |
|
|
$ |
1,256,633 |
|
|
$ |
2,622,864 |
|
|
$ |
2,816,038 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 14. Related Party Transactions
The Company had sales of approximately $404,000 and $169,000 during the six months ended December
31, 2006 and 2005, respectively, to a distributor (the related party) owned by Jeffrey Farber.
Mr. Farber is a member of the Board of Directors, as well as the son of William Farber, who is the
Chairman of the Board and principal shareholder of the Company. Accounts receivable includes
amounts due from the related party of approximately $91,000 and $84,000 at December 31, 2006 and
2005, respectively. In managements opinion, the terms of these transactions were not more
favorable to the related party than they would have been to a non-related party.
In January 2005, Lannett Holdings, Inc. entered into an agreement in which the Company purchased
for $100,000 and future royalty payments the proprietary rights to manufacture and distribute a
product for which Pharmeral, Inc. owns the ANDA. This agreement is subject to the Companys
ability to obtain FDA approval to use the proprietary rights. In the event that an approval can
not be obtained, Pharmeral, Inc. must repay the $100,000 to the Company. Accordingly, the Company
has treated this payment as a prepaid asset. Arthur Bedrosian,
18
President of the Company, Inc. was
formerly the President and Chief Executive Officer and currently owns 100% of Pharmeral, Inc. This
transaction was approved by the Board of Directors of the Company and in their opinion the terms
were not more favorable to the related party than they would have been to a non-related party.
Note 15. Material Contract with Supplier
Jerome Stevens Pharmaceuticals agreement:
The Companys primary finished product inventory supplier is Jerome Stevens Pharmaceuticals, Inc.
(JSP), in Bohemia, New York. Purchases of finished goods inventory from JSP accounted for
approximately 69% and 61% of the Companys inventory purchases during the three and six month
periods ended December 31, 2006. JSP accounted for 55% and 58% of finished goods inventory
purchases during the three and six month periods ended December 31, 2005. On March 23, 2004, the
Company entered into an agreement with JSP for the exclusive distribution rights in the United
States to the current line of JSP products, in exchange for four million (4,000,000) shares of the
Companys common stock. The JSP products covered under the agreement included Butalbital, Aspirin,
Caffeine with Codeine Phosphate capsules, Digoxin tablets and Levothyroxine Sodium tablets, sold
generically and under the brand name Unithroid®. The term of the agreement is ten years, beginning
on March 23, 2004 and continuing through March 22, 2014. Both Lannett and JSP have the right to
terminate the contract if one of the parties does not cure a material breach of the contract within
thirty (30) days of notice from the non-breaching party.
During the term of the agreement, the Company is required to use commercially reasonable efforts to
purchase minimum dollar quantities of JSPs products being distributed by the Company. The minimum
quantity to be
purchased in the first year of the agreement is $15 million. Thereafter, the minimum quantity to
be purchased increases by $1 million per year up to $24 million for the last year of the ten-year
contract. The Company has met the minimum purchase requirement for the first two years of the
contract, but there is no guarantee that the Company will be able to continue to do so in the
future. If the Company does not meet the minimum purchase requirements, JSPs sole remedy is to
terminate the agreement.
Under the agreement, JSP is entitled to nominate one person to serve on the Companys Board of
Directors (the Board) provided, however, that the Board shall have the right to reasonably
approve any such nominee in order to fulfill its fiduciary duty by ascertaining that such person
was suitable for membership on the board of a publicly traded corporation. Suitability is
determined by, but not limited to, the requirements of the Securities and Exchange Commission, the
American Stock Exchange, and other applicable laws, including the Sarbanes-Oxley Act of 2002. As
of December 31, 2006, JSP has not exercised the nomination provision of the agreement. The
agreement was included as an Exhibit in the Current Report on Form 8-K filed by the Company on May
5, 2004, as subsequently amended.
Management determined that the intangible product rights asset created by this agreement was
impaired as of March 31, 2005. Refer to Form 10-K dated June 30, 2006, Note 1 Intangible Assets
for additional disclosure and discussion of this impairment.
Other agreements:
In August 2005, the Company signed an agreement with a finished goods provider to purchase, at
fixed prices, and distribute a certain generic pharmaceutical product in the United States.
Purchases of finished goods inventory from this provider accounted for approximately 13% and 17% of
the Companys inventory purchases during the three and six month periods ended December 31, 2006.
This provider accounted for 17% and 10% of the Companys inventory purchases during the three and
six month periods ended December 31, 2005. The term of the agreement is three years, beginning on
August 22, 2005 and continuing through August 21, 2008.
During the term of the agreement, the Company has committed to provide a rolling twelve month
forecast of the estimated Product requirements to this provider. The first three months of the
rolling twelve month forecast are binding and constitute a firm order.
19
Note 16. Contingencies
The Company monitors its compliance with all environmental laws. Any compliance costs which may be
incurred are contingent upon the results of future site monitoring and will be charged to
operations when incurred. No monitoring costs were incurred during the three months ended December
31, 2006 and 2005.
The Company is currently engaged in several civil actions as a co-defendant with many other
manufacturers of Diethylstilbestrol (DES), a synthetic hormone. Prior litigation established that
the Companys pro rata share of any liability is less than one-tenth of one percent. The Company
was represented in many of these actions by the insurance company with which the Company maintained
coverage during the time period that damages were alleged to have occurred. The insurance company
denies coverage for actions alleging involvement of the Company filed after January 1, 1992. With
respect to these actions, the Company paid nominal damages or stipulated to its pro rata share of
any liability. The Company has either settled or is currently defending over 500 such claims. At
this time, management is unable to estimate a range of loss, if any, related to these actions.
Management believes that the outcome of these cases will not have a material adverse impact on the
financial position or results of operations of the Company.
In addition to the matters reported herein, the Company is involved in litigation which arises in
the normal course of business. In the opinion of management, the resolution of these lawsuits will
not have a material adverse effect on the consolidated financial position or results of operations.
20
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Introduction
The following information should be read in conjunction with the consolidated financial statements
and notes in Part I, Item 1 of this Quarterly Report and with Managements Discussion and Analysis
of Financial Condition and Results of Operations contained in the Companys Annual Report on Form
10-K for the fiscal year ended June 30, 2006.
This Report on Form 10-Q and certain information incorporated herein by reference contain
forward-looking statements which are not historical facts made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are
not promises or guarantees and investors are cautioned that all forward looking statements involve
risks and uncertainties, including but not limited to the impact of competitive products and
pricing, product demand and market acceptance, new product development, the regulatory environment,
including without limitation, reliance on key strategic alliances, availability of raw materials,
fluctuations in operating results and other risks detailed from time to time in the Companys
filings with the Securities and Exchange Commission. These statements are based on managements
current expectations and are naturally subject to uncertainty and changes in circumstances. We
caution you not to place undue reliance upon any such forward-looking statements which speak only
as of the date made. Lannett is under no obligation to, and expressly disclaims any such obligation
to, update or alter its forward-looking statements, whether as a result of new information, future
events or otherwise.
Critical Accounting Policies
The discussion and analysis of our financial condition and results of operations are based upon our
consolidated financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States of America. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported amount of assets
and liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities
at the date of our financial statements. Actual results may differ from these estimates under
different assumptions or conditions.
Critical accounting policies are defined as those that are reflective of significant judgments and
uncertainties, and potentially result in materially different results under different assumptions
and conditions. We believe that our critical accounting policies include those described below.
Revenue Recognition - The Company recognizes revenue when its products are shipped, and when title
and risk of loss have transferred to the customer and provisions for estimates, including rebates,
promotional adjustments, price adjustments, returns, chargebacks, and other potential adjustments
are reasonably determinable. Accruals for these provisions are presented in the consolidated
financial statements as rebates and chargebacks payable and reductions to net sales.
The change in the reserves for various sales adjustments may not be proportional to the change in
sales because of changes in both the product mix and the customer mix. Increased sales to
wholesalers will generally require additional rebates. Incentives offered to increase sales vary
from product to product. Provisions for estimated rebates and promotional and other credits are
estimated based on historical experience, estimated customer inventory levels, and contract terms.
Provisions for other customer credits, such as price adjustments, returns, and chargebacks require
management to make subjective judgments. Unlike branded innovator companies, Lannett does
not use information about product levels in distribution channels from third-party sources, such as
IMS Health and NDC Health, in estimating future returns and other credits. Lannett calculates a
chargeback/rebate rate based on
contractual terms with its customers and applies this rate to customer sales. The major variable
affecting this rate is customer mix, and estimates of expected customer mix are based on historical
experience and sales
21
expectations. The chargeback/rebate reserve is reviewed on a monthly basis by
management using several ratios and metrics. Lannetts methodology for estimating reserves in the
three months ended December 31, 2006 has been consistent with previous periods.
The Company ships its products to the warehouses of its wholesale and retail chain customers. When
the Company and a customer reach an agreement for the supply of a product, the customer will
generally continue to purchase the product, stock its warehouse, and resell the product to its own
customers. The customer will continually reorder the product as its warehouse is depleted. The
Company generally has no minimum size orders for its customers. Additionally, most warehousing
customers prefer not to stock excess inventory levels due to the additional carrying costs and
inefficiencies created by holding excess inventory. As such, the Companys customers continually
reorder the Companys products. It is common for the Companys customers to order the same
products on a monthly basis. For generic pharmaceutical manufacturers, it is critical to ensure
that customers warehouses are adequately stocked with its products. This is important due to the
fact that several generic competitors compete for the consumer demand for a given product.
Availability of inventory ensures that a manufacturers product is considered. Otherwise, retail
prescriptions would be filled with competitors products. For this reason, the Company
periodically offers incentives to its customers to purchase its products. These incentives are
generally up-front discounts off its standard prices at the beginning of a generic campaign launch
for a newly-approved or newly-introduced product, or when a customer purchases a Lannett product
for the first time. Customers generally inform the Company that such purchases represent an
estimate of expected resales for a period of time. This period of time is generally up to three
months. The Company records this revenue, net of any discounts offered and accepted by its
customers at the time of shipment. The shelf-life of the Companys products ranges from 18 months
to 36 months from the time of manufacture. The Company monitors its customers purchasing trends
to identify any significant lapses in purchasing activity. If the Company observes a lack of
recent activity, inquiries will be made to such customer regarding the success of the customers
resale efforts. The Company attempts to minimize any potential return (or shelf life issues) by
maintaining an active dialogue with the wholesale customers.
Chargebacks The provision is based upon contracted prices with customers, and the accuracy of
this provision is affected by changes in product sales mix and delays in selling products through
distributors. This is considered the most significant and complex estimate used in the recognition
of revenue. The chargeback is initiated when the Company sells its products to indirect
customers such as independent pharmacies, managed care organizations, hospitals, nursing homes,
and group purchasing organizations. The Company enters into agreements with its indirect customers
to establish pricing for certain products. The indirect customers then select wholesalers from
which to purchase the products at these contractual prices.
Upon the sale of a product to a wholesaler, the Company will estimate the chargeback provision
required, based upon estimated purchases by indirect customers, each of whom may have varying
contracted prices. Once the actual sale to the indirect customer occurs, the wholesaler will
request a chargeback credit from the Company. The chargeback is the difference between the
contractual price with the indirect customer and the wholesalers invoice price, if the price sold
to the indirect customer is lower than the direct price to the wholesaler. The provision for
chargebacks is based on expected sell-through levels by the Companys wholesale customers to the
indirect customers. As sales increase to the large wholesale customers, such as Cardinal Health,
AmerisourceBergen, and McKesson, the reserve for chargebacks will also generally increase. The
size of the chargeback increase depends on the product and customer mix, as different products and
customers will have different chargeback rates determined by the contractual sales prices. The
Company continually monitors the reserve for chargebacks and makes adjustments as appropriate.
Since the chargeback is initiated upon the transfer or sale of the product from the wholesaler to
the indirect customer, there is typically a delay in processing the chargeback, based on the time
to sell the product. Thus, the estimated chargeback reserve at the time of sale may vary from
actual, based on this time delay and the product sales mix going through each distributor. The
Company closely monitors this activity to ensure the estimates accurately reflect actual activity.
Rebates Rebates are offered to the Companys key customers to promote customer loyalty and
encourage greater product sales. These rebate programs provide customers with rebate credits upon
attainment of pre-established volumes or attainment of net sales milestones for a specified period.
Other promotional programs are
22
incentive programs offered to the customers. At the time of
shipment, the Company estimates reserves for rebates and other promotional credit programs based on
the specific terms in each agreement. The reserve for rebates increases as sales to certain
wholesale and retail customers increase. However, these rebate programs are tailored to the
customers individual programs. Hence, the reserve will depend on the mix of customers that
comprise such rebate programs.
Returns Consistent with industry practice, the Company has a product returns policy that allows
certain customers to return product within a specified period prior to and subsequent to the
products lot expiration date in exchange for a credit to be applied to future purchases. The
Companys policy requires that the customer obtain approval from the Company for any qualifying
return. The Company estimates its provision for returns based on historical experience, changes to
business practices, and credit terms. While such experience has allowed for reasonable estimations
in the past, history may not always be an accurate indicator of future returns. The Company
continually monitors the provisions for returns and makes adjustments when management believes that
actual product returns may differ from established reserves. Generally, the reserve for returns
increases as net sales increase. The reserve for returns is included in the rebates and
chargebacks payable account on the balance sheet.
Other Adjustments Other adjustments consist primarily of price adjustments, also known as shelf
stock adjustments, which are credits issued to reflect decreases in the selling prices of the
Companys products that customers have remaining in their inventories at the time of the price
reduction. Decreases in selling prices are discretionary decisions made by management to reflect
competitive market conditions. Amounts recorded for estimated shelf stock adjustments are based
upon specified terms with direct customers, estimated declines in market prices, and estimates of
inventory held by customers. The Company regularly monitors these and other factors and evaluates
the reserve as additional information becomes available. Other adjustments are included in the
rebates and chargebacks payable account on the balance sheet.
The following tables identify the reserves for each major category of revenue allowance and a
summary of the activity for the six months ended December 31, 2006 and 2005:
For the six months ended December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Category |
|
Chargebacks |
|
Rebates |
|
Returns |
|
Other |
|
Total |
Reserve balance as of June 30, 2006 |
|
$ |
10,137,400 |
|
|
$ |
2,183,100 |
|
|
$ |
416,000 |
|
|
$ |
275,600 |
|
|
$ |
13,012,100 |
|
Actual credits issued related to sales
recorded in prior fiscal years |
|
|
(10,120,000 |
) |
|
|
(1,702,800 |
) |
|
|
(869,500 |
) |
|
|
(219,000 |
) |
|
|
(12,911,300 |
) |
Reserves or (reversals) charged during Fiscal
2007 related to sales recorded in prior fiscal
years |
|
|
|
|
|
|
(300,000 |
) |
|
|
460,000 |
|
|
|
|
|
|
|
160,000 |
|
Reserves charged to net sales during fiscal
2007 related to sales recorded in fiscal 2007 |
|
|
15,851,400 |
|
|
|
5,750,100 |
|
|
|
590,000 |
|
|
|
350,000 |
|
|
|
22,541,500 |
|
Actual credits issued related to sales
recorded in Fiscal 2007 |
|
|
(10,065,500 |
) |
|
|
(3,808,500 |
) |
|
|
(254,700 |
) |
|
|
(115,000 |
) |
|
|
(14,243,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve balance as of December 31, 2006 |
|
$ |
5,803,300 |
|
|
$ |
2,121,900 |
|
|
$ |
341,800 |
|
|
$ |
291,600 |
|
|
$ |
8,558,600 |
|
23
For the six months ended December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Category |
|
Chargebacks |
|
Rebates |
|
Returns |
|
Other |
|
Total |
Reserve Balance as of June 30, 2005 |
|
$ |
7,999,700 |
|
|
$ |
1,028,800 |
|
|
$ |
1,692,000 |
|
|
$ |
29,500 |
|
|
$ |
10,750,000 |
|
Actual credits issued related to sales
recorded in prior fiscal years |
|
|
(7,100,000 |
) |
|
|
(950,000 |
) |
|
|
(1,450,000 |
) |
|
|
(29,500 |
) |
|
|
(9,529,500 |
) |
Reserves or (reversals) charged during
Fiscal 2006 related to sales recorded in
prior fiscal years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserves charged to net sales during
fiscal 2006 related to sales recorded in
fiscal 2006 |
|
|
10,756,100 |
|
|
|
2,697,600 |
|
|
|
602,900 |
|
|
|
470,300 |
|
|
|
14,526,900 |
|
Actual credits issued related to sales
recorded in Fiscal 2006 |
|
|
(3,674,300 |
) |
|
|
(2,487,100 |
) |
|
|
(129,400 |
) |
|
|
(382,300 |
) |
|
|
(6,673,100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Balance as of December 31, 2005 |
|
$ |
7,981,500 |
|
|
$ |
289,300 |
|
|
$ |
715,500 |
|
|
$ |
88,000 |
|
|
$ |
9,074,300 |
|
Credits issued during the quarter that relate to prior year sales are charged against the
opening balance. Since reserves are assessed and recorded in aggregate, any potential additional
reserves or reversals of reserves have historically offset each other. The table above shows the
effects of reversals within the rebate and return categories. It is the Companys intention that
all reserves be charged to sales in the period that the sale is recognized, however, due to the
nature of this estimate, it is possible that the Company may sometimes need to increase or decrease
the reserve based on prior period sales. If that were to occur, management would disclose that
information at that time. If the historical data the Company uses and the assumptions management
makes to calculate its estimates of future returns, chargebacks, and other credits do not
accurately approximate future activity, its net sales, gross profit, net income and earnings per
share could change. However, management believes that these estimates are reasonable based upon
historical experience and current conditions.
Since the Company monitors and assesses these reserves in aggregate, the rates of reserves will
vary, as well as the category under which the credit falls. This variability comes about when the
Company is working with indirect customers to compete with the pricing of other generic companies.
The Company is currently working on improving computer systems to improve the accuracy of tracking
and processing chargebacks and rebates. Improvements to automate calculation of reserves will not
only reduce the potential for human error, but also will result in more in-depth analysis and
improved customer interaction for resolution of open credits.
The rate of credits issued is monitored by the Company on a quarterly basis. The Company may
change the estimate of future reserves based on the amount of credits processed, or the rate of
sales made to indirect customers. The decrease of reserves to $8,559,000 at December 31, 2006
from $13,012,000 at June 30, 2006 is due to the timing of credits being processed by the customers
and by the Company. Approximately 99% of the reserve balance from June 30, 2006 has been processed
through December 31, 2006. Improved communication with wholesale customers has improved throughout
Fiscal 2007. The result is that a significant amount of credits had been processed, and have
reduced the liability as of December 31, 2006. Management estimates reserves based on sales mix.
A comparison to wholesaler inventory reports is performed quarterly, in order to justify the
balance of unclaimed chargebacks and rebates. The Company has historically found a direct
correlation between the calculation of the reserve based on sales mix, and the wholesaler inventory
analysis.
Each category of reserve shown has decreased since June 30, 2006, except for a slight increase in
the other reserves. An increased level of chargebacks and rebates processed by customers and
improved processing by the Company has led to this change. On a quarter to quarter basis, the
chargeback reserves may fluctuate, due to the increasingly competitive generic pharmaceutical
market. The increased competition in certain drugs and increase in chargebacks has resulted in
decreased prices to Lannett customers. Recent quarters have seen declining net sales prices in
certain products, and increases in others.
Accounts Receivable - The Company performs credit evaluations of its customers and adjusts credit
limits based upon payment history and the customers current credit worthiness, as determined by a
review of available credit information. The Company continuously monitors collections and payments
from its customers and maintains a provision for estimated credit losses based upon historical
experience and any specific customer collection issues
24
that have been identified. While such
credit losses have historically been within both the Companys expectations and the provisions
established, the Company cannot guarantee that it will continue to experience the same credit loss
rates that it has in the past.
The Company also regularly monitors customer Accounts Receivable (AR) balances through a tool known
as Days Sales Outstanding (DSO). This calculation for Net DSO begins with the Gross AR less the
Rebates and Chargeback reserve. This net amount is then divided by the average daily net sales for
the period. The table below shows the results of these calculations for the relevant periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months ended |
|
Fiscal Year ended |
|
Six Months ended |
|
|
12/31/05 |
|
6/30/06 |
|
12/31/06 |
Net DSO (in days) |
|
|
48 |
|
|
|
68 |
|
|
|
74 |
|
Gross DSO (in days) |
|
|
63 |
|
|
|
77 |
|
|
|
72 |
|
The Gross DSO above shows the result of the same calculation without regard to rebates and
chargebacks. It is generally higher than the Net DSO calculation. The Company monitors both Net
DSO and Gross DSO as an overall check on collections and reasonableness of reserves. In order to
be effective indicators, both types of DSO are evaluated on a quarterly basis. The Gross DSO
calculation provides management with an understanding of the frequency of customer payments, and
the ability to process customer payments and deductions. The Net DSO calculation provides
management with an understanding of the relationship of the A/R balance net of the reserve
liability compared to net sales after reserves charged during the period.
The Companys payment terms are consistent with the generic industry at 60 days for payment from
all customers, including wholesalers. Net DSO for the Fiscal 2007 first quarter, net of rebates
and chargebacks, increased as a result of additional sales made during the most recent period, plus
an unusually low A/R balance at the end of the second quarter of Fiscal 2006, December 31, 2005.
This low balance in the prior year was due to wholesale customers who had paid the balance owed to
Lannett in a timely manner, but had not taken chargebacks before the balance sheet date of December
31, 2005. Thus, the reserve for chargebacks remained high as of the balance sheet date, while the
A/R balance was reduced. Gross DSO has also increased since the prior year. This is primarily due
to increasing sales in the latter months of the quarter. Management expects the Gross DSO
calculation to approximate 60 days. Significant variances greater or less than 60 are reviewed
and, if necessary, action is taken.
Inventories - The Company values its inventory at the lower of cost (determined by the first-in,
first-out method) or market, regularly reviews inventory quantities on hand, and records a
provision for excess and obsolete inventory based primarily on estimated forecasts of product
demand and production requirements. The Companys estimates of future product demand may prove to
be inaccurate, in which case it may have understated or overstated the provision required for
excess and obsolete inventory. In the future, if the Companys inventory is determined to be
overvalued, the Company would be required to recognize such costs in cost of goods sold at the time
of such determination. Likewise, if inventory is determined to be undervalued, the Company may have
recognized excess cost of goods sold in previous periods and would be required to recognize such
additional operating income at the time of sale.
Stock Options Statement of Financial Accounting Standards (SFAS) No. 123 (revised 2004),
Share-Based Payment, (123(R)) was adopted effective July 1, 2005. The Company applied the
standard using the modified prospective-transition method with no restatement of prior periods.
Prior to July 1, 2005, the Company accounted for those plans under the recognition and measurement
provisions of APB 25, and related Interpretations, as
permitted by SFAS 123. No stock-based employee compensation cost was recognized in the Statement
of Operations for the year ended June 30, 2005, as all options granted had an exercise price equal
to the market value of the underlying common stock on the date of the grant.
25
Since the standard was applied using the modified-prospective-transition-method, prior periods have
not been restated. Under this method, the Company is required to record compensation expense for
all awards granted after the date of adoption and for the unvested portion of previously granted
awards that remain outstanding as of the beginning of the period of adoption. Share-based
compensation cost is measured using the Black-Scholes option pricing model. The following table
highlights relevant stock-option plan information as of December 31:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
Total share-based compensation expense |
|
$ |
515,000 |
|
|
$ |
686,000 |
|
|
|
|
|
|
|
|
|
|
Total compensation cost related to non-vested awards not yet recognized |
|
$ |
2,111,000 |
|
|
$ |
1,034,000 |
|
|
|
|
|
|
|
|
|
|
Weighted average period over which it is to be recognized |
|
1.7 years |
|
2.0 years |
Results of Operations Three months ended December 31, 2006 compared with three months
ended December 31, 2005
Net sales for the three months ended December 31, 2006 (Fiscal 2007) increased 50% to $22,916,000
from $15,229,000 for the three months ended December 31, 2005 (Fiscal 2006). The increase was
primarily due to greater demand for generic medication used to treat thyroid deficiency, greater
demand for generic antibiotics, and new products that were approved by the FDA in the current or
previous year. The Company was able to increase sales of thyroid medication through a new customer
acquisition and expanded sales to existing customers. In the prior year, the thyroid medications
were declining, due to a delay in the AB rating of Levothyroxine. In the current year, the
increase is likely due to Lannetts ability to provide the product quickly and cost effectively to
all of our customers. The following table highlights the reasons for the increase, and the
percentage each area had on the overall increase of $7,687,000:
|
|
|
|
|
Description |
|
% of increase |
Greater demand/volume |
|
|
111 |
% |
New product launches |
|
|
14 |
% |
Marketing agreements |
|
|
38 |
% |
Existing product changes |
|
|
-63 |
% |
|
|
|
|
|
Total |
|
|
100 |
% |
The majority of the increases are due to increased volumes. However, these increases may not be
indicative of the full year sales growth. Existing product changes are also primarily driven by
volume, with a small amount of decline due to pricing.
The existing product sales decline can be attributed to several products. Sales of products used
in the treatment of epilepsy decreased by approximately $1.5 million in Fiscal 2007 because new
manufacturers have entered the market, affecting sales volume. Sales of migraine headache
pharmaceuticals declined $675,000. This decline can be attributed to a combination of lower
product sales prices and lower volumes, a result of increased competition. Sales of drugs used in
hormone replacement therapy declined nearly $100,000 in Fiscal 2007 because of greater competition
and pricing pressure added by new competitors in the marketplace.
The Company sells its products to customers in various categories. The table below identifies the
Companys approximate net sales to each category:
26
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Customer Category |
|
2006 |
|
|
2005 |
|
Wholesaler/Distributor |
|
$ |
12,393,000 |
|
|
$ |
10,494,000 |
|
Retail Chain |
|
|
9,023,000 |
|
|
|
2,053,000 |
|
Mail-Order Pharmacy |
|
|
1,476,000 |
|
|
|
1,904,000 |
|
Private Label |
|
|
24,000 |
|
|
|
778,000 |
|
|
|
|
|
|
|
|
Total |
|
$ |
22,916,000 |
|
|
$ |
15,229,000 |
|
|
|
|
|
|
|
|
The increase in sales to wholesaler/distributor customers is due mainly to current year improvement
over prior year issues associated with Levothyroxine Sodium tablets. Excess product already at
customer locations in 2005 resulted in sales declines in the quarter ended December 31, 2005. In
the quarter ended December 31, 2006, the excess inventory and returns of this product were no
longer an issue, and the product was again being sold on a regular basis. Retail chain sales
improved over the prior year because of a new customer agreement entered during the quarter ended
December 31, 2006.
Cost of sales (excluding amortization of intangible asset) for the second quarter of Fiscal 2007
increased 114% to $17,244,000 from $8,064,000 in Fiscal 2006. The increase is due to the 50%
increase in sales which was driven mostly by volume. In addition, new product sales and marketing
agreements consisted of products that have higher costs to produce or purchase. Gross profit
margins (excluding amortization of intangible asset) for the second quarter of Fiscal 2007 and
Fiscal 2006 were 25% and 47%, respectively. While the Company is continuously striving to keep
product costs low, there can be no guarantee that profit margins will not fluctuate in future
periods. Pricing pressure from competitors and costs of producing or purchasing new drugs may also
fluctuate in the future. Changes in the future sales product mix may also occur. As can be seen in
the mix of increased sales, the greatest increases are of products that are distributed, and not
manufactured. These costs have caused the margin percentage to decrease. These changes may affect
the gross profit percentage in future periods.
Research and development (R&D) expenses in the second quarter decreased 36% to $1,538,000 for
Fiscal 2007 from $2,421,000 for Fiscal 2006. The decrease is primarily due to a dedicated effort
to control R&D costs, while waiting for the approval from the FDA for a number of drugs. The
Company expenses all production costs as R&D until the drug is approved by the FDA. R&D expenses
may fluctuate from period to period, based on R&D plans for submission to the FDA.
Selling, general and administrative expenses in the second quarter decreased 11% to $1,962,000 in
Fiscal 2007 from $2,205,000 in Fiscal 2006. The decrease is primarily due to the buildup of
infrastructure in the prior year, and decreased costs of compliance with Sarbanes-Oxley. This
buildup in the prior year has resulted in current year savings in consulting and other outside
services. Other costs are being incurred to facilitate improvements in the Companys
infrastructure. These costs are expected to be temporary investments in the future of the Company
and may not continue at the same level. However, as the Company continues to invest in technology,
the Company may need to invest additional funds in technology or professional services.
Amortization expense for the intangible asset for the three months ended December 31, 2006 and 2005
was approximately $446,000 and $446,000, respectively. The amortization expense relates to the
March 23, 2004 exclusive marketing and distribution rights agreement with JSP. For the remaining
seven years of the contract, the Company will incur annual amortization expense of approximately
$1,785,000.
The Companys interest expense in the second quarter decreased to $68,000 in Fiscal 2007 from
$85,000 in Fiscal 2006 primarily as a result of a decrease in principal balances and the
refinancing of mortgage debt in November 2005. Interest income in the second quarter increased to
$112,000 in Fiscal 2007 from $99,000 in Fiscal 2006.
The Companys income tax expense in the second quarter decreased to $708,000 in Fiscal 2007 from
$843,000 in Fiscal 2006, with a 40% effective tax rate in both periods.
27
The Company reported net income of $1,062,000 in the second quarter of Fiscal 2007, or $0.04 basic
and diluted income per share, as compared to net income of $1,264,000 in the second quarter of
Fiscal 2006, or $0.05 basic and diluted income per share.
Results of Operations Six months ended December 31, 2006 compared with six months ended
December 31, 2005
Net sales for the six months ended December 31, 2006 (Fiscal 2007) increased 55% to $44,884,000
from $28,870,000 for the six months ended December 31, 2005 (Fiscal 2006). The increase was
primarily due to greater demand for generic medication used to treat thyroid deficiency, greater
demand for generic antibiotics, and new products that were approved by the FDA in the current or
previous year. The Company was able to increase sales of thyroid medication through a new customer
acquisition in the first quarter of Fiscal 2007 and to existing customers. In the prior year, the
thyroid medications were declining, due to a delay in the AB rating of Levothyroxine. In the
current year, the increase is due to Lannetts ability to provide the product quickly and cost
effectively to all of our customers. The following table highlights the reasons for the increase,
and the percentage each area had on the overall increase of $16,014,000:
|
|
|
|
|
Description |
|
% of increase |
Greater demand/volume |
|
|
71 |
% |
New product launches |
|
|
19 |
% |
Marketing agreements |
|
|
59 |
% |
Existing product changes |
|
|
-49 |
% |
|
|
|
|
|
Total |
|
|
100 |
% |
The majority of the increases are due to increased volumes. However, these increases may not be
indicative of the full year sales growth. Existing product changes are also primarily driven by
volume, with a small amount of decline due to pricing.
The existing product sales decline can be attributed to several products. Sales of products used
in the treatment of epilepsy decreased by approximately $2.2 million in Fiscal 2007 because new
manufacturers have entered the market, affecting sales volume. Sales of migraine headache
pharmaceuticals declined $1.4 million. This decline can be attributed to a combination of lower
product sales prices, and increased competition. Sales of drugs used in hormone replacement
therapy declined nearly $900,000 in Fiscal 2007 because of greater competition and pricing pressure
added by new competitors in the marketplace.
The Company sells its products to customers in various categories. The table below identifies the
Companys approximate net sales to each category:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended December 31, |
|
Customer Category |
|
2006 |
|
|
2005 |
|
Wholesaler/Distributor |
|
$ |
28,592,000 |
|
|
$ |
18,239,000 |
|
Retail Chain |
|
|
13,186,000 |
|
|
|
5,458,000 |
|
Mail-Order Pharmacy |
|
|
3,009,000 |
|
|
|
3,505,000 |
|
Private Label |
|
|
97,000 |
|
|
|
1,668,000 |
|
|
|
|
|
|
|
|
Total |
|
$ |
44,884,000 |
|
|
$ |
28,870,000 |
|
|
|
|
|
|
|
|
The increase in sales to wholesaler/distributor customers is due mainly to improvement in sales of
Levothyroxine Sodium tablets. The prior year sales were affected by lower-than-expected demand and
lower sales to wholesalers.
In the six months ended December 31, 2006, the excess inventory and returns of this product were no
longer an issue, and the product was again being sold on a regular basis. Retail Chain sales of
Levothyroxine also increased, a result of a new customer acquired in the current fiscal year.
28
Cost of sales (excluding amortization of intangible asset) for the first six months increased 102%
to $30,091,000 in Fiscal 2007 from $14,927,000 in Fiscal 2006. The increase is due to the 55%
increase in sales which was driven mostly by volume. In addition, new product sales and marketing
agreements that were entered consisted primarily of products that have higher costs to produce or
purchase, increasing the cost of sales percentage. Gross profit margins (excluding amortization
of intangible asset) for the first six months of Fiscal 2007 and Fiscal 2006 were 33% and 48%,
respectively. While the Company is continuously striving to keep product costs low, there can be
no guarantee that profit margins will not fluctuate in future periods. Pricing pressure from
competitors and costs of producing or purchasing new drugs may also fluctuate in the future.
Changes in the future sales product mix may also occur. These changes may affect the gross profit
percentage in future periods.
Research and development (R&D) expenses in the first six months decreased 7% to $3,317,000 for
Fiscal 2007 from $3,562,000 for Fiscal 2006. The decrease is primarily due to a slight decrease in
production of drugs in development and preparation for submission to the FDA. The Company expenses
all production costs as R&D until the drug is approved by the FDA. R&D expenses may fluctuate from
period to period, based on R&D plans for submission to the FDA.
Selling, general and administrative expenses in the first six months increased 33% to
$6,344,000 in Fiscal 2007 from $4,782,000 in Fiscal 2006. Almost the entire increase is due to
$1,230,000 of expenses incurred in Fiscal 2007 that relate to marketing agreements tied to sales of
new generic products. The remaining increase in expense is due to additional administrative
personnel costs, related to increased headcount, professional fees and computer support fees.
While the Company is focused on controlling costs, increases in personnel costs may have an
ongoing, and longer lasting impact on the administrative cost structure. Other costs are being
incurred to facilitate improvements in the Companys infrastructure. These costs are expected to
be temporary investments in the future of the Company and may not continue at the same level.
However, as the Company continues to invest in technology, the Company may need to invest
additional funds in technology or professional services.
Amortization expense for the intangible asset for the six months ended December 31, 2006 and 2005
was approximately $892,000 and $892,000, respectively. The amortization expense relates to the
March 23, 2004 exclusive marketing and distribution rights agreement with JSP.
The Companys interest expense in the first six months decreased to $132,000 in Fiscal
2007 from $193,000 in Fiscal 2006 primarily as a result of a decrease in principal balances and the
refinancing of mortgage debt in November 2005. Interest income in the first six months
decreased to $211,000 in Fiscal 2007 from $247,000 in Fiscal 2006.
The Companys income tax expense in the first six months decreased to $1,729,000 in
Fiscal 2007 from $1,896,000 in Fiscal 2006, with a 40% effective tax rate in Fiscal 2007 and 39.8%
effective tax rate in Fiscal 2006.
The Company reported net income of $2,590,000 in the first six months of Fiscal 2007, or
$0.11 basic and diluted income per share, as compared to net income of $2,865,000 in the first six
months Fiscal 2006, or $0.12 basic and diluted income per share.
Liquidity and Capital Resources
The Company has historically financed its operations by cash flow from operations. At December 31,
2006, working capital was $25,669,000, as compared to $22,862,000 at June 30, 2006, an increase of
$2,807,000. Net cash provided by operating activities of $6,255,000 in the first six months of
Fiscal 2007 is due to net income of
$2,590,000, and adjustments for the effects of non-cash items of $3,730,000 and decrease in
operating assets and liabilities of $65,000. Significant changes in operating assets and
liabilities are comprised of:
|
|
|
Trade accounts receivable net of rebates and chargebacks payable decreased $6,703,000
due to an increase in processing of usual and customary chargeback and rebate credits
claimed by customers; |
|
|
|
|
A $1,991,000 decrease in inventories resulting from increased demand for products, |
29
|
|
|
A $3,846,000 increase in accounts payable due to timing of payments at the end of the
month combined with increased spending on products for resale, primarily Levothyroxine
Sodium tablets; and |
|
|
|
|
A $1,017,000 decrease in prepaid taxes resulting from receipt of a refund on federal
taxes. |
The net cash used in investing activities of $4,523,000 for the six months ended December 31, 2006
was due to an additional $5,347,000 note receivable signed with an API provider and $1,069,000
investment in infrastructure. This was partially offset by the sale of a portion of the Companys
investment securities, which consist primarily of U. S. government and agency marketable debt
securities.
The following table summarizes the remaining repayments of debt, including sinking fund
requirements as of December 31, 2006 for the subsequent twelve month periods:
|
|
|
|
|
Twelve Month |
|
Amounts Payable |
|
Periods |
|
to Institutions |
|
2007 |
|
$ |
592,000 |
|
2008 |
|
|
604,000 |
|
2009 |
|
|
538,000 |
|
2010 |
|
|
4,808,000 |
|
2011 |
|
|
343,000 |
|
Thereafter |
|
|
1,056,000 |
|
|
|
|
|
|
|
$ |
7,941,000 |
|
|
|
|
|
The Company has a $3,000,000 line of credit from Wachovia Bank, N.A. that bears interest at the
prime interest rate less 0.25% (8.0% at December 31, 2006). The line of credit was renewed and
extended to November 30, 2007. At December 31, 2006 and 2005, the Company had $0 outstanding under
the line of credit. The line of credit is collateralized by substantially all of the Companys
assets. The Company currently has no plans to borrow under this line of credit.
The terms of the line of credit, the loan agreement, the related letter of credit and the 2003 Loan
Financing require that the Company meet certain financial covenants and reporting standards,
including the attainment of standard financial liquidity and net worth ratios. As of December 31,
2006, the Company has complied with such terms, and successfully met its financial covenants.
In July 2004, the Company received $500,000 of grant funding from the Commonwealth of Pennsylvania,
acting through the Department of Community and Economic Development. The grant funding program
requires the Company to use the funds for machinery and equipment located at their Pennsylvania
locations, hire an additional 100 full-time employees by June 30, 2006, operate its Pennsylvania
locations a minimum of five years and meet certain matching investment requirements. If the
Company fails to comply with any of the requirements above, the Company would be liable to the full
amount of the grant funding ($500,000). The Company records the unearned grant funds as a
liability until the Company complies with all of the requirements of the grant funding program. On
a quarterly basis, the Company will monitor its progress in fulfilling the requirements of the
grant funding program and will determine the status of the liability. As of December 31, 2006, the
Company has recognized the grant funding as a current liability under the caption of Unearned Grant
Funds. Currently, the grant funding is recognized as a short term liability under the caption of
Unearned Grant Funds, since the Company has not yet met the requirement to add 100 full-time
employees. However, the Company is requesting an extension of this
obligation to add 100 employees, since the other requirement related to use of funds has been met
already, and the requirement to operate its Pennsylvania locations is still ongoing.
Except as set forth in this report, the Company is not aware of any trends, events or uncertainties
that have or are reasonably likely to have a material adverse impact on the Companys short-term or
long-term liquidity or financial condition.
30
Prospects for the Future
The Company has several generic products under development. These products are all
orally-administered topical and parenteral products designed to be generic equivalents to brand
named innovator drugs. The Companys developmental drug products are intended to treat a diverse
range of indications. As the oldest generic drug manufacturer in the country, formed in 1942,
Lannett currently owns several ANDAs for products which it does not manufacture and market. These
ANDAs are simply dormant on the Companys records. Occasionally, the Company reviews such ANDAs to
determine if the market potential for any of these older drugs has recently changed, so as to make
it attractive for Lannett to reconsider manufacturing and selling it. If the Company makes the
determination to introduce one of these products into the consumer marketplace, it must review the
ANDA and related documentation to ensure that the approved product specifications, formulation and
other factors meet current FDA requirements for the marketing of that drug. The Company would then
redevelop the product and submit it to the FDA for supplemental approval. The FDAs approval
process for ANDA supplements is similar to that of a new ANDA. Generally, in these situations, the
Company must file a supplement to the FDA for the applicable ANDA, informing the FDA of any
significant changes in the manufacturing process, the formulation, or the raw material supplier of
the previously-approved ANDA.
A majority of the products in development represent either previously approved ANDAs that the
Company is planning to reintroduce (ANDA supplements), or new formulations (new ANDAs). The
products under development are at various stages in the development cycleformulation, scale-up,
and/or clinical testing. Depending on the complexity of the active ingredients chemical
characteristics, the cost of the raw material, the FDA-mandated requirement of bioequivalence
studies, the cost of such studies and other developmental factors, the cost to develop a new
generic product varies. It can range from $100,000 to $1 million. Some of Lannetts developmental
products will require bioequivalence studies, while others will notdepending on the FDAs Orange
Book classification. Since the Company has no control over the FDA review process, management is
unable to anticipate whether or when it will be able to begin producing and shipping additional
products.
In addition to the efforts of its internal product development group, Lannett has contracted with
several outside firms for the formulation and development of several new generic drug products.
These outsourced R&D products are at various stages in the development cycle formulation,
analytical method development and testing and manufacturing scale-up. These products are
orally-administered solid dosage, injectables, as well as topical products intended to treat a
diverse range of medical indications. It is the Companys intention to ultimately transfer the
formulation technology and manufacturing process for all of these R&D products to the Companys own
commercial manufacturing sites. The Company initiated these outsourced R&D efforts to complement
the progress of its own internal R&D efforts.
Lannett also manufactures and sells products which are equivalent to innovator drugs which are
grand-fathered, under FDA rules, prior to the passage of the Hatch-Waxman Act of 1984. The FDA
allows generic manufacturers to produce and sell generic versions of such grand-fathered products
by simply performing and internally documenting the products stability over a period of time.
Under this scenario, a generic company can forego the time required for FDA ANDA approval.
The Company signed supply and development agreements with Olive Healthcare, of India; Orion Pharma,
of Finland; Azad Pharma AG, of Switzerland, and is in negotiations with companies in Israel and
Greece for similar new product initiatives, in which Lannett will market and distribute products
manufactured by third parties.
Lannett intends to use its strong customer relationships to build its market share for such
products, and increase future revenues and income.
The majority of the Companys R&D projects are being developed in-house under Lannetts direct
supervision and with Company personnel. Hence, the Company does not believe that its outside
contracts for product development and manufacturing supply are material in nature, nor is the
Company substantially dependent on the services rendered by such outside firms. Since the Company
has no control over the FDA review process, management is unable to anticipate whether or when it
will be able to begin producing and shipping such additional products.
Lannett may increase its focus on certain specialty markets in the generic pharmaceutical industry.
Such a focus is intended to provide Lannett customers with increased product alternatives in
categories with relatively few
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