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 SEPTEMBER
30, 2006.
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o |
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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.
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 October 31, 2006, there were 24,154,374 shares of the issuers common stock, $.001 par value,
outstanding.
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
LANNETT COMPANY, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
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September 30, 2006 |
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June 30, 2006 |
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(unaudited) |
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ASSETS |
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Current Assets |
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Cash |
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$ |
555,245 |
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$ |
468,359 |
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Trade accounts receivable (net of allowance of $250,000) |
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28,549,837 |
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24,921,671 |
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Inventories |
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10,940,816 |
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11,476,503 |
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Interest receivable |
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33,210 |
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193,549 |
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Prepaid taxes |
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2,195,782 |
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3,212,511 |
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Deferred tax assets current portion |
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1,461,172 |
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1,461,172 |
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Other current assets |
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1,734,754 |
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1,753,082 |
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Total Current Assets |
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45,470,816 |
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43,486,847 |
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Property, plant, and equipment |
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28,769,430 |
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28,782,350 |
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Less accumulated depreciation |
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(9,686,103 |
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(9,136,801 |
) |
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19,083,327 |
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19,645,549 |
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Construction in progress |
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2,254,855 |
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1,955,508 |
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Investment securities available for sale |
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4,599,066 |
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5,621,609 |
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Note receivable |
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5,940,338 |
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3,182,498 |
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Intangible asset (product rights) net of accumulated amortization |
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13,385,002 |
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13,831,168 |
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Deferred tax asset |
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17,029,341 |
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18,070,674 |
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Other assets |
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249,663 |
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198,211 |
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TOTAL ASSETS |
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$ |
108,012,408 |
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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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Accounts payable |
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$ |
226,840 |
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$ |
763,744 |
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Accrued expenses |
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7,464,898 |
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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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1,130,706 |
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1,130,706 |
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Rebates and chargebacks payable |
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11,636,171 |
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13,012,084 |
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Total Current Liabilities |
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20,958,615 |
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20,624,428 |
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Long term debt, less current portion |
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6,904,215 |
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7,065,986 |
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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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TOTAL LIABILITIES |
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30,408,564 |
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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 $0.001;
issued and outstanding, 24,148,014 and 24,141,325 shares, respectively |
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24,148 |
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24,141 |
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Additional paid in capital |
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72,032,020 |
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71,742,402 |
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Retained earnings |
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5,984,261 |
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4,456,387 |
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Accumulated other comprehensive loss |
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(42,015 |
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(72,444 |
) |
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77,998,414 |
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76,150,486 |
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Less: Treasury stock at cost - 50,900 shares |
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394,570 |
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394,570 |
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TOTAL SHAREHOLDERS EQUITY |
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77,603,844 |
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75,755,916 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
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$ |
108,012,408 |
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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.
3
LANNETT COMPANY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)
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Three months ended |
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September 30, |
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2006 |
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2005 |
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Net sales |
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$ |
21,967,826 |
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$ |
13,641,532 |
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Cost of sales (excluding amortization of intangible asset) |
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12,846,394 |
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6,862,785 |
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Gross profit |
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9,121,432 |
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6,778,747 |
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Research and development expenses |
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1,778,427 |
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1,141,101 |
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Selling, general, & administrative expenses |
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4,382,500 |
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2,577,135 |
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Amortization of intangible assets |
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446,166 |
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446,166 |
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Operating income |
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2,514,339 |
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2,614,345 |
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Other income (expense): |
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Interest expense |
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(64,026 |
) |
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(108,003 |
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Interest income |
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98,608 |
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148,049 |
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34,582 |
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40,046 |
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Income before income tax expense |
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2,548,921 |
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2,654,391 |
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Income tax expense |
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1,021,047 |
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1,053,415 |
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Net income |
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$ |
1,527,874 |
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$ |
1,600,976 |
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Basic earnings per share |
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$ |
0.06 |
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$ |
0.07 |
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Diluted earnings per share |
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$ |
0.06 |
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$ |
0.07 |
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Basic weighted average number of shares |
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24,147,941 |
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24,110,790 |
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Diluted weighted average number of shares |
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24,170,735 |
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24,117,149 |
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The accompanying notes to consolidated financial statements are an integral part of these
statements.
4
LANNETT COMPANY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS EQUITY
(UNAUDITED)
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Additional |
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Retained |
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Accumulated Other |
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Total |
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Common Stock |
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Paid-in |
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Earnings |
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Treasury |
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Comprehensive |
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Shareholders |
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Shares |
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Amount |
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Capital |
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(Deficit) |
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Stock |
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Loss, net |
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Equity |
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Balance at June 30, 2006 |
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24,141,325 |
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$ |
24,141 |
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$ |
71,742,402 |
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$ |
4,456,387 |
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$ |
(394,570 |
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$ |
(72,444 |
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$ |
75,755,916 |
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Shares issued in connection
with employee stock purchase plan |
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6,689 |
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7 |
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32,344 |
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32,351 |
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Stock Compensation expense |
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257,274 |
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257,274 |
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Other comprehensive income |
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30,429 |
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30,429 |
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Net Income |
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1,527,874 |
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1,527,874 |
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Balance at September 30, 2006 |
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24,148,014 |
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$ |
24,148 |
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$ |
72,032,020 |
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$ |
5,984,261 |
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$ |
(394,570 |
) |
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$ |
(42,015 |
) |
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$ |
77,603,844 |
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The accompanying notes to consolidated financial statements are an integral part of these
statements.
5
LANNETT COMPANY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
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Three months ended |
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September 30, |
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2006 |
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2005 |
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OPERATING ACTIVITIES: |
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Net income |
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$ |
1,527,874 |
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$ |
1,600,976 |
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Adjustments to reconcile net income to
net cash provided by operating activities: |
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Depreciation and amortization |
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1,079,675 |
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954,300 |
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Deferred tax (benefit) expense |
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1,041,333 |
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(27,715 |
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Stock compensation expense |
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257,274 |
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327,889 |
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Noncash gain from sale of asset |
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(8,208 |
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Changes in assets and liabilities which provided (used) cash: |
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Trade accounts receivable |
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(5,004,079 |
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(3,934,972 |
) |
Inventories |
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535,687 |
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(803,262 |
) |
Prepaid taxes |
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1,016,729 |
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1,057,641 |
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Prepaid expenses and other assets |
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127,215 |
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100,730 |
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Accounts payable |
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(536,904 |
) |
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(240,314 |
) |
Accrued expenses |
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2,247,014 |
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1,598,168 |
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Net cash provided by operating activities |
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2,283,610 |
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633,441 |
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INVESTING ACTIVITIES: |
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Purchases of property, plant and equipment(including
construction in progress) |
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(372,429 |
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(615,137 |
) |
Proceeds from sale of asset |
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10,000 |
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Sales of investment securities available for sale |
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1,052,972 |
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1,327,777 |
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Issuance of note receivable |
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(2,757,840 |
) |
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(2,000,000 |
) |
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Net cash used in investing activities |
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(2,067,297 |
) |
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(1,287,360 |
) |
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FINANCING ACTIVITIES: |
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Repayments of debt |
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(161,771 |
) |
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(564,016 |
) |
Proceeds from issuance of stock |
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32,344 |
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|
33,420 |
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Net cash used in financing activities |
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(129,427 |
) |
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(530,596 |
) |
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NET INCREASE/(DECREASE) IN CASH |
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86,886 |
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(1,184,515 |
) |
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CASH, BEGINNING OF PERIOD |
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|
468,359 |
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|
4,165,601 |
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CASH, END OF PERIOD |
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$ |
555,245 |
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|
$ |
2,981,086 |
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SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION - |
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Interest paid |
|
$ |
35,114 |
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|
$ |
108,003 |
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Income taxes paid |
|
$ |
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|
$ |
|
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|
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|
The accompanying notes to consolidated financial statements are an integral part of these
statements.
6
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 period ended September 30, 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 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 subsidiary, Lannett Holdings,
Inc.
Revenue Recognition The Company recognizes revenue when its products are shipped, 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 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, is 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
products. The indirect customers then select a wholesaler from which to receive the products at
these contractual prices.
7
Upon the sale of a product to a wholesaler, the Company will record the estimated chargeback
provision required, based upon estimated indirect customers purchases and the contract prices with
those indirect customers. Once the sale to the indirect customer occurs, the wholesaler will
request 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 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 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 three months ended September 30, 2006 and 2005:
For the three months ended:
September 30, 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 |
|
|
(7,907,000 |
) |
|
|
(1,702,800 |
) |
|
|
(699,000 |
) |
|
|
(219,000 |
) |
|
|
(10,527,800 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserves or (reversals) charged during
Fiscal 2007 related to sales recorded
in prior fiscal years |
|
|
|
|
|
|
(300,000 |
) |
|
|
300,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserves charged to net sales during
fiscal 2007 related to sales recorded
in fiscal 2007 |
|
|
9,040,100 |
|
|
|
2,393,900 |
|
|
|
450,000 |
|
|
|
120,000 |
|
|
|
12,004,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual credits issued related to sales
recorded in Fiscal 2007 |
|
|
(2,224,700 |
) |
|
|
(615,200 |
) |
|
|
|
|
|
|
(12,200 |
) |
|
|
(2,852,100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve balance as of September 30, 2006 |
|
$ |
9,045,800 |
|
|
$ |
1,959,000 |
|
|
$ |
467,000 |
|
|
$ |
164,400 |
|
|
$ |
11,636,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
For the three months ended:
September 30, 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 |
|
|
(5,277,200 |
) |
|
|
(712,000 |
) |
|
|
(164,000 |
) |
|
|
(20,500 |
) |
|
|
(6,173,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
5,147,100 |
|
|
|
1,500,200 |
|
|
|
12,100 |
|
|
|
413,300 |
|
|
|
7,072,700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual credits issued related to sales
recorded in fiscal 2006 |
|
|
(576,400 |
) |
|
|
(207,600 |
) |
|
|
|
|
|
|
|
|
|
|
(784,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve balance as of September 30, 2005 |
|
$ |
7,293,200 |
|
|
$ |
1,609,400 |
|
|
$ |
1,540,100 |
|
|
$ |
422,300 |
|
|
$ |
10,865,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
September 30, 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 September 30, 2006 and 2005 was approximately
$8,900 and $5,500, 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
9
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 months ended September 30, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
Medical Indication |
|
9/30/06 |
|
|
9/30/05 |
|
Migraine Headache |
|
$ |
2,491,000 |
|
|
$ |
3,173,000 |
|
Epilepsy |
|
|
2,658,000 |
|
|
|
3,360,000 |
|
Heart Failure |
|
|
1,503,000 |
|
|
|
1,748,000 |
|
Thyroid Deficiency |
|
|
6,509,000 |
|
|
|
3,857,000 |
|
Antibiotics |
|
|
6,530,000 |
|
|
|
|
|
Other |
|
|
2,277,000 |
|
|
|
1,503,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
21,968,000 |
|
|
$ |
13,641,000 |
|
|
|
|
|
|
|
|
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 September 30, 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, we are 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.
We measured 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 three months ended September 30, 2006:
|
|
|
|
|
Risk-free interest rate |
|
|
5.00 |
% |
Expected volatility |
|
|
59 |
% |
Expected dividend yield |
|
|
0.0 |
% |
Expected term (in years) |
|
|
5.00 |
|
Forfeiture rate |
|
|
5.0 |
% |
Weighted average fair value at date of grant |
|
$ |
3.36 |
|
There were no options issued during the three months ended September 30, 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
10
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.
The forfeiture rate assumption is the estimated annual rate at which unvested awards will 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 historical rate to
reflect its 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 September 30, 2005 to 5% at September 30,
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 September 30, |
|
|
2006 |
|
2005 |
|
|
Fair Value |
|
Fair Value |
Method used to account for share-based compensation |
|
|
|
|
|
|
|
|
Share-based compensation under SFAS 123(R) |
|
$ |
257,274 |
|
|
$ |
327,889 |
|
Tax benefit at effective rate |
|
$ |
46,940 |
|
|
$ |
79,350 |
|
A summary of award activity under the Plans as of September 30, 2006 and 2005, and changes
during the three months then ended, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
Average |
|
|
|
|
|
|
Average |
|
Aggregate |
|
Remaining |
|
|
|
|
|
|
Exercise |
|
Intrinsic |
|
Contractual |
|
|
Awards |
|
Price |
|
Value |
|
Life |
Outstanding at July 1, 2006 |
|
|
792,003 |
|
|
$ |
10.89 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
134,262 |
|
|
|
4.61 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
2,720 |
|
|
|
16.86 |
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2006 |
|
|
923,545 |
|
|
$ |
9.96 |
|
|
$ |
|
|
|
|
7.7 |
|
Outstanding at September 30,
2006 and not yet vested |
|
|
435,962 |
|
|
$ |
8.35 |
|
|
$ |
|
|
|
|
8.8 |
|
Exercisable at September 30, 2006 |
|
|
487,583 |
|
|
$ |
11.40 |
|
|
$ |
|
|
|
|
6.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
Average |
|
|
|
|
|
|
Average |
|
Aggregate |
|
Remaining |
|
|
|
|
|
|
Exercise |
|
Intrinsic |
|
Contractual |
|
|
Awards |
|
Price |
|
Value |
|
Life |
Outstanding at July 1, 2005 |
|
|
857,108 |
|
|
$ |
11.93 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2005 |
|
|
857,108 |
|
|
$ |
11.93 |
|
|
$ |
|
|
|
|
8.2 |
|
Outstanding at September 30,
2005 and not yet vested |
|
|
428,437 |
|
|
$ |
12.69 |
|
|
$ |
|
|
|
|
8.4 |
|
Exercisable at September 30, 2005 |
|
|
428,671 |
|
|
$ |
11.16 |
|
|
$ |
|
|
|
|
7.8 |
|
11
As of September 30, 2006, there was approximately $1,327,000 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 1.4 years.
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 February 2006, the FASB issued SFAS No. 155, Accounting for Certain Hybrid Financial
Instrumentsan amendment of FASB Statements No. 133 and 140 (SFAS 155). This Statement amends
FASB Statements No. 133, Accounting for Derivative Instruments and Hedging Activities, and No. 140,
Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Liabilities.
SFAS 155 resolves issues addressed in Statement 133 Implementation Issue No. D1, Application of
Statement 133 to Beneficial Interests in Securitized Financial Assets. This Statement is
effective for all financial instruments acquired or issued after the beginning of an entitys first
fiscal year that begins after September 15, 2006. Management has not yet determined the effect
that adoption of this statement will have upon the financial statements.
In March 2006, the FASB issued SFAS No. 156, Accounting for Servicing of Financial Assetsan
amendment of FASB Statement No. 140 (SFAS 156). This Statement amends FASB Statement No. 140,
Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Liabilities, with
respect to the accounting for
separately recognized servicing assets and servicing liabilities. This statement sets forth
obligation requirements for recognizing servicing assets or liabilities and gives guidance for
measuring and presenting the obligations. The effective date of SFAS 156 is for fiscal years
beginning after September 15, 2006. Lannett will be required to adopt the guidance of SFAS 156
beginning July 1, 2007. Management has not yet determined the effect that adoption of this
statement will have upon the 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 has
not completed its study of the effects of adopting this standard.
12
In September 2006, the FASB issued SFAS No. 158, Employers Accounting for Defined Benefit Pension
and Other Postretirement Plansan amendment of FASB Statements No. 87, 88, 106, and 132(R) (SFAS
158). This Statement improves financial reporting by requiring an employer to recognize the
overfunded or underfunded status of a defined benefit postretirement plan (other than a
multiemployer plan) as an asset or liability in its statement of financial position and to
recognize changes in that funded status in the year in which the changes occur through
comprehensive income of a business entity or changes in unrestricted net assets of a not-for-profit
organization. This Statement also improves financial reporting by requiring an employer to measure
the funded status of a plan as of the date of its year-end statement of financial position, with
limited exceptions. SFAS 158 is effective as of the end of the fiscal year ending after December
15, 2006. The Company has concluded that the adoption of this statement will have no impact on the
financial statements or disclosures of the Company.
In April 2006, the FASB issued FASB Staff Position No. FIN 46(R)6, Determining the Variability to
Be Considered in Applying FASB Interpretation No. 46(R) (FSP No. 46(R)6). This pronouncement
provides guidance on how a reporting enterprise should determine the variability to be considered
in applying FASB Interpretation No. 46 (revised December 2003), Consolidation of Variable Interest
Entities, which could impact the assessment of whether certain variable interest entities are
consolidated. FSP No. 46(R)6 was effective for the Company on July 1, 2006. FSP No. 46(R)6
has had no impact to the Company in the current year.
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 tax
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. 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.
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 January 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, and has had no
effect on the financial statements of the Company in the current year.
13
Note 4. 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. Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
2006 |
|
|
June 30, 2006 |
|
Raw material |
|
$ |
4,400,897 |
|
|
$ |
5,143,714 |
|
Work-in-process |
|
|
1,401,166 |
|
|
|
1,438,794 |
|
Finished goods |
|
|
4,732,808 |
|
|
|
4,511,274 |
|
Packaging supplies |
|
|
405,945 |
|
|
|
382,721 |
|
|
|
|
|
|
|
|
|
|
$ |
10,940,816 |
|
|
$ |
11,476,503 |
|
|
|
|
|
|
|
|
The preceding amounts are net of inventory reserves of $1,278,912 and $1,054,498 at September 30,
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 September 30, 2006 and 2005 was approximately $634,000 and
$508,000, respectively. Property, plant and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
June 30, |
|
|
|
Useful Lives |
|
|
2006 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
Land |
|
|
|
|
|
$ |
233,414 |
|
|
$ |
233,414 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Building and improvements |
|
10 - 39 |
years |
|
|
10,665,236 |
|
|
|
10,612,954 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Machinery and equipment |
|
5 - 10 |
years |
|
|
17,044,077 |
|
|
|
17,109,279 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Furniture and fixtures |
|
5 - 7 |
years |
|
|
826,703 |
|
|
|
826,703 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
28,769,430 |
|
|
$ |
28,782,350 |
|
|
|
|
|
|
|
|
|
|
|
|
14
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 three month period ended September 30, 2006.
The amortized cost, gross unrealized gains and losses, and fair value of the Companys
available-for-sale securities are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 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 |
|
|
3,568,548 |
|
|
|
8,218 |
|
|
|
(54,569 |
) |
|
|
3,522,197 |
|
Mortgage-Backed Securities |
|
|
296,985 |
|
|
|
|
|
|
|
(18,558 |
) |
|
|
278,427 |
|
Asset-Backed Securities |
|
|
303,557 |
|
|
|
|
|
|
|
(5,115 |
) |
|
|
298,442 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
4,669,090 |
|
|
$ |
8,218 |
|
|
$ |
(78,242 |
) |
|
$ |
4,599,066 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 September 30, 2006 are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, 2006 |
|
|
|
Available for Sale |
|
|
|
Amortized |
|
|
Fair |
|
|
|
Cost |
|
|
Value |
|
Due in one year or less |
|
$ |
|
|
|
$ |
|
|
Due after one year through five years |
|
|
3,076,956 |
|
|
|
3,053,171 |
|
Due after five years through ten years |
|
|
658,493 |
|
|
|
653,929 |
|
Due after ten years |
|
|
933,641 |
|
|
|
891,966 |
|
|
|
|
|
|
|
|
|
|
$ |
4,669,090 |
|
|
$ |
4,599,066 |
|
|
|
|
|
|
|
|
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.
15
The table below indicates the length of time individual securities have been in a continuous
unrealized loss position as of September 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 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 |
|
|
12 |
|
|
|
1,110,877 |
|
|
|
(9,259 |
) |
|
|
831,390 |
|
|
|
(45,310 |
) |
|
|
1,942,267 |
|
|
|
(54,569 |
) |
Mortgage-Backed Securities |
|
|
3 |
|
|
|
146,235 |
|
|
|
(2,359 |
) |
|
|
369,213 |
|
|
|
(16,199 |
) |
|
|
515,448 |
|
|
|
(18,558 |
) |
Asset-Backed Securities |
|
|
3 |
|
|
|
61,420 |
|
|
|
(847 |
) |
|
|
237,023 |
|
|
|
(4,268 |
) |
|
|
298,443 |
|
|
|
(5,115 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total temporarily impaired
investment securities |
|
|
18 |
|
|
$ |
1,318,532 |
|
|
$ |
(12,465 |
) |
|
$ |
1,437,626 |
|
|
$ |
(65,777 |
) |
|
$ |
2,756,158 |
|
|
$ |
(78,242 |
) |
|
|
|
|
|
|
|
|
|
|
|
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 September
30, 2006, there were approximately 18 out of 25 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 quarters ended September 30,
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 $5.9 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 Company has approved this extension until 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 all of
this loan is deemed uncollectible, a reserve will be established to recognize the amount considered
uncollectible.
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 September 30, 2006). The line of credit was renewed and
extended to November 30, 2007. At September 30, 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.
16
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 September 30, 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:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2006 |
|
PIDC Regional Center, LP III loan |
|
$ |
4,500,000 |
|
|
$ |
4,500,000 |
|
|
Pennsylvania Industrial Development Authority loan |
|
|
1,204,692 |
|
|
|
1,221,780 |
|
|
Pennsylvania Department of Community & Economic
Development loan |
|
|
466,590 |
|
|
|
476,560 |
|
|
Tax-exempt bond loan (PAID) |
|
|
900,983 |
|
|
|
955,566 |
|
|
Equipment loan |
|
|
962,656 |
|
|
|
1,042,786 |
|
|
|
|
|
|
|
|
|
Total debt |
|
|
8,034,921 |
|
|
|
8,196,692 |
|
|
Less current portion |
|
|
1,130,706 |
|
|
|
1,130,706 |
|
|
|
|
|
|
|
|
|
Long term debt |
|
$ |
6,904,215 |
|
|
$ |
7,065,986 |
|
|
|
|
|
|
|
|
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 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 $1,204,692 outstanding as of September 30,
2006, and $69,536 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 two and three quarter percent per annum. As of
September 30, 2006, $466,590 is outstanding, and $85,654 is currently due.
17
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 September 30, 2006 was 3.9%. At September 30, 2006, the Company has $900,983
outstanding on the Authority loan, of which $654,996 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 September 30, 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 September 30, 2006, the Company has outstanding $962,656 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 September 30, 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 September 30, 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 September 30 are as follows:
|
|
|
|
|
12 month period ended |
|
Amounts Payable |
|
September 30, |
|
to Institutions |
|
2007 |
|
$ |
1,131,000 |
|
2008 |
|
|
672,000 |
|
2009 |
|
|
569,000 |
|
2010 |
|
|
180,000 |
|
2011 |
|
|
4,600,000 |
|
Thereafter |
|
|
883,000 |
|
|
|
|
|
|
|
$ |
8,035,000 |
|
|
|
|
|
18
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/(benefit) 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 September
30, 2006 and 2005 was $1,021,047 and $1,053,415, 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 September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
|
Net Income |
|
|
Shares |
|
|
Net Income |
|
|
Shares |
|
|
|
(Numerator) |
|
|
(Denominator) |
|
|
(Numerator) |
|
|
(Denominator) |
|
Basic earnings per share factors |
|
$ |
1,527,874 |
|
|
|
24,147,941 |
|
|
$ |
1,600,976 |
|
|
|
24,110,790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive stock options |
|
|
|
|
|
|
22,794 |
|
|
|
|
|
|
|
6,359 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share factors |
|
$ |
1,527,874 |
|
|
|
24,170,735 |
|
|
$ |
1,600,976 |
|
|
|
24,117,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share |
|
$ |
0.06 |
|
|
|
|
|
|
$ |
0.07 |
|
|
|
|
|
Diluted earnings per share |
|
$ |
0.06 |
|
|
|
|
|
|
$ |
0.07 |
|
|
|
|
|
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 September 30, 2006 and 2005 were 736,503
and 825,608, 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 September 30, 2006 and 2005:
19
COMPREHENSIVE INCOME (LOSS)
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
|
9/30/2006 |
|
|
9/30/2005 |
|
Other Comprehensive Income (Loss): |
|
|
|
|
|
|
|
|
Unrealized Holding Gain (Loss) on Securities |
|
$ |
50,715 |
|
|
$ |
(69,287 |
) |
Tax at effective rate |
|
|
(20,286 |
) |
|
|
27,715 |
|
|
|
|
|
|
|
|
Total Unrealized Gain (Loss) on Securities, Net |
|
|
30,429 |
|
|
|
(41,572 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other Comprehensive Income (Loss) |
|
|
30,429 |
|
|
|
(41,572 |
) |
Net Income |
|
|
1,527,874 |
|
|
|
1,600,976 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Comprehensive Income |
|
$ |
1,558,303 |
|
|
$ |
1,559,404 |
|
|
|
|
|
|
|
|
Note 14. Related Party Transactions
The Company had sales of approximately $263,000 and $162,000 during the three months ended
September 30, 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 $157,000 and $131,000 at September 30,
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, 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 51% of the Companys inventory purchases during the first quarter of Fiscal 2007 and
62% during the first quarter of Fiscal 2006. 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
20
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 is
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
September 30, 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 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 23% of the
Companys inventory purchases during the first quarter of Fiscal 2007. There were no inventory
purchases from this provider during the first quarter of Fiscal 2006. 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.
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 September
30, 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.
21
|
|
|
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
22
this rate is customer mix, and estimates of expected customer mix are based on historical
experience and sales 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 September 30, 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-
23
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 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 three months ended September 30, 2006 and 2005:
For the three months ended:
September 30, 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 |
|
|
(7,907,000 |
) |
|
|
(1,702,800 |
) |
|
|
(699,000 |
) |
|
|
(219,000 |
) |
|
|
(10,527,800 |
) |
Reserves or (reversals) charged during
Fiscal 2007 related to sales recorded
in prior fiscal years |
|
|
|
|
|
|
(300,000 |
) |
|
|
300,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserves charged to net sales during
Fiscal 2007 related to sales recorded
in fiscal 2007 |
|
|
9,040,100 |
|
|
|
2,393,900 |
|
|
|
450,000 |
|
|
|
120,000 |
|
|
|
12,004,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual credits issued-related to sales
recorded in Fiscal 2007 |
|
|
(2,224,700 |
) |
|
|
(615,200 |
) |
|
|
|
|
|
|
(12,200 |
) |
|
|
(2,852,100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve balance as of September 30, 2006 |
|
$ |
9,045,800 |
|
|
$ |
1,959,000 |
|
|
$ |
467,000 |
|
|
$ |
164,400 |
|
|
$ |
11,636,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24
For the three months ended:
September 30, 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 |
|
|
(5,277,200 |
) |
|
|
(712,000 |
) |
|
|
(164,000 |
) |
|
|
(20,500 |
) |
|
|
(6,173,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserves or (reversals) charged during
current fiscal year related to sales
recorded in prior fiscal years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserves charged to net sales during
fiscal 2006 related to sales recorded
in fiscal 2006 |
|
|
5,147,100 |
|
|
|
1,500,200 |
|
|
|
12,100 |
|
|
|
413,300 |
|
|
|
7,072,700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual credits issued related to sales
recorded in Fiscal 2006 |
|
|
(576,400 |
) |
|
|
(207,600 |
) |
|
|
|
|
|
|
|
|
|
|
(784,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve balance as of September 30, 2005 |
|
$ |
7,293,200 |
|
|
$ |
1,609,400 |
|
|
$ |
1,540,100 |
|
|
$ |
422,300 |
|
|
$ |
10,865,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 $11,636,000 at September 30, 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 80% of the reserve balance from June 30, 2006 has been processed
through the first quarter of Fiscal 2007. 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 the reserve for
returns. An increased level of chargebacks processed by customers and 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 sales prices in certain products, and increases in others.
25
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 that have been identified. While such
credit losses have historically been within the both 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter ended |
|
Fiscal Year |
|
Quarter ended |
|
|
9/30/05 |
|
ended 6/30/06 |
|
9/30/06 |
Net DSO (in days) |
|
|
26.4 |
|
|
|
67.9 |
|
|
|
70.8 |
|
Gross DSO (in days) |
|
|
63.0 |
|
|
|
76.5 |
|
|
|
73.3 |
|
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 first quarter of Fiscal 2006, September 30, 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
September 30, 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 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
26
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.
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.
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
September 30, |
|
|
2006 |
|
2005 |
Total share-based compensation expense |
|
$ |
257,000 |
|
|
$ |
328,000 |
|
Total compensation cost related to non-vested awards not
yet recognized |
|
$ |
1,327,000 |
|
|
$ |
1,932,000 |
|
Weighted average period over which it is to be recognized |
|
1.4 years |
|
1.5 years |
Results of Operations Three months ended September 30, ,2006 compared with three months
ended September 30, 2005
Net sales for the three months ended September 30, 2006 (Fiscal 2007) increased 61% to
$21,968,000 from $13,642,000 for the three months ended September 30, 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 $8,326,000.
|
|
|
|
|
Description |
|
% of increase |
|
Greater demand/volume |
|
|
33 |
% |
New product launches |
|
|
24 |
% |
Marketing agreements |
|
|
78 |
% |
Existing product changes |
|
|
-35 |
% |
|
|
|
|
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 Primidone
tablets decreased by approximately $700,000 in Fiscal 2007 because the Company is no longer the
primary manufacturer of the 50mg Primidone tablet. Sales of Butalbital with Aspirin and Caffeine
capsules and Butalbital with Aspirin and Caffeine with Codeine, declined $900,000. This decline
can be attributed to a combination of lower product sales prices, and increased competition.
Methyltestosterone and Esterefied Estrogens sales declined nearly $800,000 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 for the three months ended September 30, 2006 and
2005:
27
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Customer Category
|
|
2006 |
|
|
2005 |
|
Wholesaler/Distributor |
|
$ |
16,199,000 |
|
|
$ |
7,746,000 |
|
Retail Chain |
|
|
4,163,000 |
|
|
|
3,405,000 |
|
Mail-Order Pharmacy |
|
|
1,533,000 |
|
|
|
1,601,000 |
|
Private Label |
|
|
73,000 |
|
|
|
890,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
21,968,000 |
|
|
$ |
13,642,000 |
|
|
|
|
|
|
|
|
The increase in sales to wholesaler/distributor customers is due mainly to issues associated with
Levothyroxine Sodium tablets in the prior year. Excess product in 2005 resulted in little or no
sales in the quarter ended September 30, 2005. In the quarter ended September 30, 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. In addition, sales of new products grew through wholesalers, which is a
typical strategy for promoting new products.
Cost of sales (excluding amortization of intangible asset) for the first quarter increased 87% to
$12,846,000 in Fiscal 2007 from $6,863,000 in Fiscal 2006. The increase is due to the 61% 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 first quarter of Fiscal 2007 and
Fiscal 2006 were 42% and 50%, 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 quarter increased 56% to $1,778,000 for
Fiscal 2007 from $1,141,000 for Fiscal 2006. The increase is primarily due to an increase 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 quarter increased 70% to $4,833,000 in
Fiscal 2007 from $2,577,000 in Fiscal 2006. The increase is primarily due to $1,300,000 of
expenses related 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 three months ended September 30, 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 and a half years of the contract, the Company will incur annual amortization
expense of approximately $1,785,000.
The Companys interest expense in the first quarter decreased to $64,000 in Fiscal 2007 from
$108,000 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 quarter decreased to
$99,000 in Fiscal 2007 from $148,000 in Fiscal 2006.
The Companys income tax expense in the first quarter decreased to $1,021,000 in Fiscal 2007 from
$1,053,000 in Fiscal 2006, with a 40% effective tax rate in both periods.
28
The Company reported net income of $1,528,000 in the first quarter of Fiscal 2007, or $0.06 basic
and diluted income per share, as compared to net income of $1,601,000 in the First Quarter Fiscal
2006, or $0.07 basic and diluted income per share.
Liquidity and Capital Resources
The Company has historically financed its operations by cash flow from operations. At September
30, 2006, working capital was $24,512,000, as compared to $22,862,000 at June 30, 2006, an increase
of $1,650,000. Net cash provided by operating activities of $2,284,000 in the first quarter of
Fiscal 2007 is due to net income of $1,528,000, and adjustments for the effects of non-cash items
of $2,370,000 and decrease in operating assets and liabilities of $1,614,000. Significant changes
in operating assets and liabilities are comprised of:
|
|
|
An increase in trade accounts receivable of $5,004,000 due to increased sales in the
first quarter of Fiscal 2007. |
|
|
|
|
A decrease in prepaid taxes as a result of receipt of $1,017,000 tax refund. |
|
|
|
|
An increase in accrued expenses resulting from personnel expenses increasing as a result
of an accrual of bonuses plus a change in timing of employee payroll during September
amounting to $0.7 million, $1.0 million accrual owed to a marketing partner as part of a
royalty agreement, and normal timing fluctuations related to receiving raw materials. |
The net cash used in investing activities of $2,067,000 for the three months ended September 30,
2006 was due to an additional $2.8 million note receivable signed with an API provider. 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 September 30, 2006 for the subsequent twelve month periods:
|
|
|
|
|
|
|
Amounts Payable |
|
Twelve Month Periods |
|
to Institutions |
|
2007 |
|
|
1,131,000 |
|
2008 |
|
|
672,000 |
|
2009 |
|
|
569,000 |
|
2010 |
|
|
180,000 |
|
2011 |
|
|
4,600,000 |
|
Thereafter |
|
|
883,000 |
|
|
|
|
|
|
|
$ |
8,035,000 |
|
|
|
|
|
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 September 30, 2006). The line of credit was renewed and
extended to November 30, 2007. At September 30, 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 September 30,
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
29
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 September 30, 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.
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.
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
30
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 market participants. While there is no guarantee that Lannett has
the market expertise or financial resources necessary to succeed in such a market specialty,
management is confident that such future focus will be well received by Lannett customers and
increase shareholder value in the long run.
The Company plans to enhance relationships with strategic business partners, including providers of
product development research, raw materials, active pharmaceutical ingredients as well as finished
goods. Management believes that mutually beneficial strategic relationships in such areas,
including potential financing arrangements, partnerships, joint ventures or acquisitions, could
allow for potential competitive advantages in the generic pharmaceutical market. For example, the
Company has entered into prepayment arrangements in exchange for discounted purchase prices on
certain active pharmaceutical ingredients (API) and oral dosage forms. The Company has also
arranged for a loan to a certain API provider as well as continued funding of recent operations of
this API provider that should facilitate the availability of difficult to source material in the
future. The Company plans to continue to explore such areas for potential opportunities to enhance
shareholder value.
31
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The Company has debt instruments with variable interest rates. The Equipment loan, amounting
to $963,000 at September 30, 2006, bears interest at a variable rate equal to the LIBOR rate plus
150 basis points. In addition, the Company has a $3 million line of credit that bears interest at
the prime interest rate less 0.25%. The Company currently has $0 outstanding under this line of
credit. Loans are collateralized by inventory, accounts receivable and other assets. The agreement
contains covenants with respect to working capital, net worth and certain ratios, as well as other
covenants.
The Company invests in U.S. treasury notes, government asset-backed securities and mortgage-backed
securities, all of which are exposed to interest rate fluctuations. The interest earned on these
investments may vary based on fluctuations in the interest rate.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The Company maintains disclosure controls and procedures that are designed to ensure that
information required to be disclosed in its Exchange Act reports is recorded, processed, summarized
and reported within the time periods specified in the Securities and Exchange Commissions rules
and forms, and that such information is accumulated and communicated to management, including the
Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions
regarding required disclosure. Management necessarily applies its judgment in assessing the costs
and benefits of such controls and procedures, which, by their nature, can provide only reasonable
assurance regarding managements control objectives.
With the participation of management, the Companys Chief Executive Officer and Chief Financial
Officer evaluated the effectiveness of the design and operation of the Companys disclosure
controls and procedures at the conclusion of the three months ended September 30, 2006. Based upon
this evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the
Companys disclosure controls and procedures were effective in ensuring that material information
required to be disclosed is included in the reports that it files with the Securities and Exchange
Commission.
Changes in Internal Controls
There were no significant changes in the Companys internal controls or, to the knowledge of
management of the Company, in other factors that could significantly affect internal controls
subsequent to the date of the Companys most recent evaluation of its disclosure controls and
procedures utilized to compile information included in this filing.
32
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Regulatory Proceedings
The Company is engaged in an industry which is subject to considerable government regulation
relating to the development, manufacturing and marketing of pharmaceutical products. Accordingly,
incidental to its business, the Company periodically responds to inquiries or engages in
administrative and judicial proceedings involving regulatory authorities, particularly the FDA and
the Drug Enforcement Agency.
DES Cases
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.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
|
(a) |
|
A list of the exhibits required by Item 601 of Regulation S-K to be filed as a part of
this Form 10-Q is shown on the Exhibit Index filed herewith. |
33
SIGNATURE
In accordance with the requirements of the Exchange Act, the registrant caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
|
LANNETT COMPANY, INC.
|
|
Dated: Nov. 8, 2006 |
By: |
/s/ Brian Kearns
|
|
|
|
Brian Kearns |
|
|
|
Vice President of Finance, Treasurer and
Chief Financial Officer |
|
|
|
|
|
|
|
|
|
|
Dated: Nov. 8, 2006 |
By: |
/s/ Arthur P. Bedrosian
|
|
|
|
Arthur P. Bedrosian |
|
|
|
President and Chief Executive Officer |
|
|
34
Exhibit Index
|
|
|
|
|
|
|
|
|
31.1
|
|
Certification of Chief Executive
Officer Pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
|
|
Filed Herewith
|
|
|
36 |
|
|
|
|
|
|
|
|
|
|
31.2
|
|
Certification of Chief Financial
Officer Pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
|
|
Filed Herewith
|
|
|
37 |
|
|
|
|
|
|
|
|
|
|
32
|
|
Certifications of Chief Executive
Officer and Chief Financial Officer
Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
|
Filed Herewith
|
|
|
38 |
|
35