e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
AND EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED March 31,
2006. |
|
|
|
o |
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES AND EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM
TO . |
Commission File No. 001-31298
LANNETT COMPANY, INC.
(Exact Name of Registrant as Specified in its Charter)
|
|
|
State of Delaware
|
|
23-0787699 |
(State of Incorporation)
|
|
(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 larger accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12B-12 of the
Exchange Act). Yes o No þ
As of April 28, 2006, there were 24,141,325 shares of the issuers common stock, $.001 par value,
outstanding.
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
LANNETT COMPANY, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
(UNAUDITED) |
|
|
|
|
|
|
3/31/2006 |
|
|
6/30/2005 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current Assets |
|
|
|
|
|
|
|
|
Cash |
|
$ |
1,729,926 |
|
|
$ |
4,165,601 |
|
Trade accounts receivable (net of allowance; 70,000 and 70,000) |
|
|
23,664,023 |
|
|
|
10,735,529 |
|
Inventories |
|
|
11,699,262 |
|
|
|
9,988,769 |
|
Prepaid taxes |
|
|
1,201,432 |
|
|
|
3,957,993 |
|
Deferred tax assets current portion |
|
|
3,182,281 |
|
|
|
3,123,953 |
|
Other current assets |
|
|
2,106,974 |
|
|
|
1,966,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
43,583,898 |
|
|
|
33,938,115 |
|
|
|
|
|
|
|
|
|
|
Property, plant, & equipment |
|
|
27,382,105 |
|
|
|
23,746,161 |
|
Less accumulated depreciation |
|
|
(8,701,345 |
) |
|
|
(7,121,313 |
) |
|
|
|
|
|
|
|
|
|
|
18,680,760 |
|
|
|
16,624,848 |
|
|
|
|
|
|
|
|
|
|
Construction in progress |
|
|
2,477,558 |
|
|
|
2,079,650 |
|
Investments available for sale |
|
|
5,584,657 |
|
|
|
7,888,708 |
|
Note receivable |
|
|
2,000,000 |
|
|
|
|
|
Intangible asset, net of accumulated amortization |
|
|
14,277,335 |
|
|
|
15,615,835 |
|
Deferred tax asset less current portion |
|
|
18,593,364 |
|
|
|
18,610,159 |
|
Other assets |
|
|
207,127 |
|
|
|
159,745 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets |
|
$ |
105,404,699 |
|
|
$ |
94,917,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,313,609 |
|
|
$ |
1,208,148 |
|
Accrued expense |
|
|
3,867,139 |
|
|
|
1,667,638 |
|
Unearned grant funds |
|
|
500,000 |
|
|
|
500,000 |
|
Current portion of long term debt |
|
|
1,130,706 |
|
|
|
2,269,776 |
|
Rebates and chargebacks |
|
|
14,698,211 |
|
|
|
10,750,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
21,509,665 |
|
|
|
16,395,562 |
|
|
|
|
|
|
|
|
|
|
Long term debt, less current portion |
|
|
7,385,431 |
|
|
|
7,262,672 |
|
Deferred tax liabilities |
|
|
2,009,582 |
|
|
|
2,009,582 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
30,904,678 |
|
|
|
25,667,816 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders Equity |
|
|
|
|
|
|
|
|
|
Common stock authorized 50,000,000 shares, par value $0.001;
issued and outstanding, 24,136,625 and 24,111,140, respectively |
|
|
24,137 |
|
|
|
24,111 |
|
Additional paid-in capital |
|
|
71,344,203 |
|
|
|
70,157,431 |
|
Retained earnings (deficit) |
|
|
3,610,744 |
|
|
|
(512,535 |
) |
Accumulated other comprehensive loss, net |
|
|
(84,493 |
) |
|
|
(25,193 |
) |
|
|
|
|
|
|
|
|
|
|
74,894,591 |
|
|
|
69,643,814 |
|
Treasury stock at cost 50,900 shares |
|
|
(394,570 |
) |
|
|
(394,570 |
) |
|
|
|
|
|
|
|
Total shareholders equity |
|
|
74,500,021 |
|
|
|
69,249,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities and Shareholders Equity |
|
$ |
105,404,699 |
|
|
$ |
94,917,060 |
|
|
|
|
|
|
|
|
The accompanying notes to consolidated financial statements are an integral part of these statements.
3
LANNETT COMPANY, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended: |
|
|
Nine months ended: |
|
|
|
(UNAUDITED) |
|
|
(UNAUDITED) |
|
|
|
3/31/2006 |
|
|
3/31/2005 |
|
|
3/31/2006 |
|
|
3/31/2005 |
|
Net sales |
|
$ |
15,737,180 |
|
|
$ |
7,603,189 |
|
|
$ |
44,607,481 |
|
|
$ |
35,533,206 |
|
Cost of sales (excluding amortization of intangible
assets) |
|
|
9,404,156 |
|
|
|
4,266,839 |
|
|
|
24,330,916 |
|
|
|
18,973,152 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
6,333,024 |
|
|
|
3,336,350 |
|
|
|
20,276,565 |
|
|
|
16,560,054 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
1,252,108 |
|
|
|
1,172,853 |
|
|
|
4,814,186 |
|
|
|
3,521,507 |
|
Selling, general, & administrative |
|
|
2,554,595 |
|
|
|
2,930,801 |
|
|
|
7,332,135 |
|
|
|
6,817,487 |
|
Amortization of intangible assets |
|
|
446,166 |
|
|
|
1,690,083 |
|
|
|
1,338,499 |
|
|
|
5,070,251 |
|
Impairment loss on intangible assets |
|
|
|
|
|
|
46,093,236 |
|
|
|
|
|
|
|
46,093,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
2,080,155 |
|
|
|
(48,550,623 |
) |
|
|
6,791,745 |
|
|
|
(44,942,427 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Realized loss on sale of investments |
|
|
(10,800 |
) |
|
|
(871 |
) |
|
|
(2,818 |
) |
|
|
(1,466 |
) |
Interest expense |
|
|
(54,646 |
) |
|
|
(96,373 |
) |
|
|
(246,853 |
) |
|
|
(245,056 |
) |
Interest income |
|
|
96,352 |
|
|
|
50,584 |
|
|
|
333,540 |
|
|
|
99,361 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30,906 |
|
|
|
(46,660 |
) |
|
|
83,869 |
|
|
|
(147,161 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
|
2,111,061 |
|
|
|
(48,597,283 |
) |
|
|
6,875,614 |
|
|
|
(45,089,588 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
|
856,402 |
|
|
|
(19,438,913 |
) |
|
|
2,752,335 |
|
|
|
(18,035,836 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
1,254,659 |
|
|
$ |
(29,158,370 |
) |
|
$ |
4,123,279 |
|
|
$ |
(27,053,752 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share |
|
$ |
0.05 |
|
|
$ |
(1.21 |
) |
|
$ |
0.17 |
|
|
$ |
(1.12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per share |
|
$ |
0.05 |
|
|
$ |
(1.21 |
) |
|
$ |
0.17 |
|
|
$ |
(1.12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average number of
shares |
|
|
24,135,723 |
|
|
|
24,103,256 |
|
|
|
24,126,588 |
|
|
|
24,092,958 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted average number of
shares |
|
|
24,201,162 |
|
|
|
24,103,256 |
|
|
|
24,174,198 |
|
|
|
24,092,958 |
|
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Retained |
|
|
|
|
|
|
Accumulated Other |
|
|
Total |
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Earnings |
|
|
Treasury |
|
|
Comprehensive |
|
|
Shareholders |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
(Deficit) |
|
|
Stock |
|
|
Loss, net |
|
|
Equity |
|
Balance at June 30, 2005 |
|
|
24,111,140 |
|
|
$ |
24,111 |
|
|
$ |
70,157,431 |
|
|
$ |
(512,535 |
) |
|
$ |
(394,570 |
) |
|
$ |
(25,193 |
) |
|
$ |
69,249,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued in connection
with employee stock purchase plan |
|
|
25,485 |
|
|
|
26 |
|
|
|
114,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114,727 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense in
connection with employee stock
options |
|
|
|
|
|
|
|
|
|
|
1,072,071 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,072,071 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized net losses on
investment
securities, net of
reclassification
adjustments and income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(59,300 |
) |
|
|
(59,300 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,123,279 |
|
|
|
|
|
|
|
|
|
|
|
4,123,279 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2006 |
|
|
24,136,625 |
|
|
$ |
24,137 |
|
|
$ |
71,344,203 |
|
|
$ |
3,610,744 |
|
|
$ |
(394,570 |
) |
|
$ |
(84,493 |
) |
|
$ |
74,500,021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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)
|
|
|
|
|
|
|
|
|
|
|
For the nine months ended |
|
|
|
3/31/2006 |
|
|
3/31/2005 |
|
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
4,123,279 |
|
|
$ |
(27,053,752 |
) |
Adjustments to reconcile net income (loss) to
net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
2,918,531 |
|
|
|
6,377,820 |
|
Impairment loss on intangible asset |
|
|
|
|
|
|
46,093,236 |
|
Stock compensation expense |
|
|
1,072,071 |
|
|
|
|
|
Changes in assets and liabilities which provided (used) cash: |
|
|
|
|
|
|
|
|
Trade accounts receivable |
|
|
(8,980,283 |
) |
|
|
16,767,510 |
|
Inventories |
|
|
(1,710,493 |
) |
|
|
(5,110,706 |
) |
Prepaid taxes |
|
|
2,756,561 |
|
|
|
(1,298,542 |
) |
Prepaid expenses and other assets |
|
|
(229,619 |
) |
|
|
(18,605,932 |
) |
Accounts payable |
|
|
105,461 |
|
|
|
(4,938,378 |
) |
Accrued expenses |
|
|
2,199,501 |
|
|
|
(1,824,429 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
2,255,009 |
|
|
|
10,406,827 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment (including
construction in progress) |
|
|
(4,033,852 |
) |
|
|
(2,878,657 |
) |
Sales (purchases) of investment securities available for sale |
|
|
2,244,751 |
|
|
|
(5,987,228 |
) |
Purchase of note receivable |
|
|
(2,000,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(3,789,101 |
) |
|
|
(8,865,885 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Repayments of debt |
|
|
(7,266,310 |
) |
|
|
(1,599,000 |
) |
Proceeds from grant funding |
|
|
|
|
|
|
500,000 |
|
Proceeds from debt, net of restricted cash released |
|
|
6,250,000 |
|
|
|
1,602,608 |
|
Purchase of treasury stock |
|
|
|
|
|
|
(394,570 |
) |
Proceeds from issuance of stock |
|
|
114,727 |
|
|
|
169,929 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
(901,583 |
) |
|
|
278,967 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET (DECREASE)/INCREASE IN CASH |
|
|
(2,435,675 |
) |
|
|
1,819,909 |
|
|
|
|
|
|
|
|
|
|
CASH, BEGINNING OF PERIOD |
|
|
4,165,601 |
|
|
|
8,966,954 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH, END OF PERIOD |
|
$ |
1,729,926 |
|
|
$ |
10,786,863 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW
INFORMATION - |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
231,853 |
|
|
$ |
245,055 |
|
|
|
|
|
|
|
|
Income taxes paid |
|
$ |
|
|
|
$ |
1,700,000 |
|
|
|
|
|
|
|
|
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.
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 our opinion, however, 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. You should not
base your estimate of our results of operations for fiscal year-end 2006 solely on our results of
operations for the nine months ended March 31, 2006. 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, 2005.
Note 2. Summary of Significant Accounting Policies
Lannett Company, Inc. and subsidiary (the Company), a Delaware corporation, develop, manufacture,
package, market, and distribute pharmaceutical products sold under generic chemical names.
The Company is engaged in an industry which is subject to considerable government regulation
related to the development, manufacturing and marketing of pharmaceutical products. In the normal
course of business, the Company periodically responds to inquiries or engages in administrative and
judicial proceedings involving regulatory authorities, particularly the Food and Drug
Administration (FDA) and the Drug Enforcement Agency (DEA).
Use
of Estimates The preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could differ from those estimates.
In the opinion of management, the accompanying unaudited consolidated financial statements contain
all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the
financial position and the results of operations and cash flows. The results of operations for
the nine months ended March 31, 2006 and 2005 are not necessarily indicative of results for the
full year. While management believes that the disclosures presented are adequate to make the
information not misleading, it is suggested that these consolidated financial statements be read in
conjunction with the consolidated financial statements and the notes included in the Companys
Annual Report on Form 10-K for the year ended June 30, 2005.
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.
7
Reclassifications
Certain reclassifications have been made to the prior periods financial
information to conform to the March 31, 2006 presentation.
Revenue
Recognition The Company recognizes revenue when its products are shipped. At this point,
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 proportionally equal to the
change in sales because of changes in both the product and the customer mix. Increased sales to
wholesalers will generally require additional rebates. Incentives offered to secure sales vary from
product to product. Provisions for estimated rebates and promotional and other credits are
estimated based on historical payment 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.
Chargebacks
The provision for chargebacks is the most significant and complex estimate used in
the recognition of revenue. The Company sells its products directly to wholesale distributors,
generic distributors, retail pharmacy chains and mail-order pharmacies. The Company also sells its
products indirectly to independent pharmacies, managed care organizations, hospitals, nursing
homes, and group purchasing organizations, collectively referred to as indirect customers. The
Company enters into agreements with its indirect customers to establish pricing for certain
products. The indirect customers then independently select a wholesaler from which to actually
purchase the products at these agreed-upon prices. The Company will provide credit to the
wholesaler for the difference between the agreed-upon 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. This credit is called a chargeback. The provision for chargebacks is
based on expected sell-through levels by the Companys wholesale customers to the indirect
customers, and estimated wholesaler inventory levels. As sales to the large wholesale customers,
such as Cardinal Health, AmerisourceBergen, and McKesson, increase, the reserve for chargebacks
will also generally increase. However, the size of the increase depends on the product mix. The
Company continually monitors the reserve for chargebacks and makes adjustments when management
believes that actual chargebacks may differ from estimated reserves. Estimated reserves are based
upon historical experience, and may change from time to time. Management re-evaluates these
reserves quarterly.
Rebates
Rebates are offered to the Companys key customers to promote customer loyalty and
encourage greater product sales. These rebate programs provide customers with rebate credits upon
attainment of pre-established volumes or attainment of net sales milestones for a specified period.
Other promotional programs are 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
select 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 pre-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
8
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 nine months ended March 31, 2006 and 2005:
For the nine months ended
March 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 Fiscal
2005 |
|
|
(7,720,000 |
) |
|
|
(1,450,900 |
) |
|
|
(1,264,800 |
) |
|
|
(27,200 |
) |
|
|
(10,462,900 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual Credits Issued-Related
To Sales Recorded in Fiscal
2006 |
|
|
(8,612,100 |
) |
|
|
(2,313,400 |
) |
|
|
(273,400 |
) |
|
|
(892,800 |
) |
|
|
(12,091,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional Reserves Charged to
Net Sales During Fiscal 2006 |
|
|
21,207,000 |
|
|
|
4,085,800 |
|
|
|
297,300 |
|
|
|
912,700 |
|
|
|
26,502,800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Balance as of March
31,
2006 |
|
$ |
12,874,600 |
|
|
$ |
1,350,300 |
|
|
$ |
451,100 |
|
|
$ |
22,200 |
|
|
$ |
14,698,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine months ended
March 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Category |
|
Chargebacks |
|
|
Rebates |
|
|
Returns |
|
|
Other |
|
|
Total |
|
Reserve
Balance as of June 30, 2004 |
|
$ |
6,484,500 |
|
|
$ |
1,864,200 |
|
|
$ |
448,000 |
|
|
$ |
88,300 |
|
|
$ |
8,885,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual Credits Issued-Related
To Sales Recorded in Fiscal 2004 |
|
|
(4,966,500 |
) |
|
|
(1,936,500 |
) |
|
|
(408,400 |
) |
|
|
(87,000 |
) |
|
|
(7,398,400 |
) |
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual Credits Issued-Related
To Sales Recorded in Fiscal 2005 |
|
|
(8,494,900 |
) |
|
|
(4,455,300 |
) |
|
|
(736,500 |
) |
|
|
(425,800 |
) |
|
|
(14,112,500 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional Reserves Charged to
Net Sales During Fiscal 2005 |
|
|
14,559,400 |
|
|
|
6,696,800 |
|
|
|
971,900 |
|
|
|
472,800 |
|
|
|
22,700,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Balance as of March 31
2005 |
|
$ |
7,582,500 |
|
|
$ |
2,169,200 |
|
|
$ |
275,000 |
|
|
$ |
48,300 |
|
|
$ |
10,075,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The chargeback reserve increased to $12,874,600 at March 31, 2006 due to an increased level of
chargebacks, as a percentage of sales, required by the wholesale distributor market. In many
cases, the increasingly competitive generic pharmaceutical market has resulted in decreased prices
to Lannett customers. This competitive environment resulted in increased chargeback reserves. The
increase in the rebate reserve to $1,350,300 at March 31, 2006 from $1,028,800 at June 30, 2005 is
related to the increase in sales for the quarter then ended.
The Company ships its products to the warehouses of its wholesale and retail chain customers. When
the Company and a customer come to an agreement for the supply of a product, the customer will
generally continue to purchase the product, stock its warehouse(s), and resell the product to its
own customers. The Companys 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 Companys products have from 18 months to 36 months of
shelf-life at the time of manufacture. The Company monitors its customers purchasing trends to
attempt 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 returns (or shelf life issues) by
maintaining an active dialogue with the customers.
The products that the Company sells are generic versions of brand named drugs. The consumer
markets for such drugs are well-established markets with many years of historically-confirmed
consumer demand. Such consumer demand may be affected by several factors, including alternative
treatments, cost, etc. However, the effects of changes in such consumer demand for the Companys
products, like generic products manufactured by other generic companies, are gradual in nature.
Any overall decrease in consumer demand for generic products generally
occurs over an extended period of time. This is because there are thousands of doctors,
prescribers, third-party payers, institutional formularies and other buyers of drugs that must
change prescribing habits and medicinal practices before such a decrease would affect a generic
drug market. If the historical data the Company uses and the assumptions management makes to
calculate its estimates of future returns, chargebacks,
10
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.
Accounts
Receivable The Company performs ongoing 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 current 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 both the Companys expectations and the provisions
established, the Company cannot guarantee that it will continue to experience the same credit loss
rates that it has in the past.
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.
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 March 31, 2006 and 2005 was approximately
$541,000 and $473,000, respectively. Depreciation expense for the nine months ended March 31, 2006
and 2005 was approximately $1,580,000 and $1,308,000, respectively.
Investment Securities 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 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 nine month period ended March 31, 2006.
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. Amortization expense
for debt acquisition costs for the three months ended March 31, 2006 and 2005 was approximately
$9,000 and $5,500, respectively. Amortization expense for debt acquisition costs for the nine
months ended March 31, 2006 and 2005 was approximately $51,000 and $16,000, respectively.
Shipping and Handling Costs The cost of shipping products to customers is recognized at the time
the products are shipped, and is included in Cost of Sales.
Research and Development Research and development expenses are charged to operations as incurred.
11
Advertising
Costs The Company charges advertising costs to operations as incurred. Advertising
expense for the three months ended March 31, 2006 and 2005 was approximately $7,000 and $16,000,
respectively. Advertising expense for the nine months ended March 31, 2006 and 2005 was $148,000
and $123,000, respectively.
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.
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,
accordingly the Company has one reporting segment. In accordance with FAS 131, the Company
aggregates its financial information for all products and reports on one operating segment. The
Companys products contain various active pharmaceutical ingredients aimed at treating a diverse
range of medical indications. The following table identifies the Companys approximate net product
sales by medical indication for the three and nine months ended March 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
Medical Indication |
|
03/31/06 |
|
|
03/31/05 |
|
|
03/31/06 |
|
|
03/31/05 |
|
Migraine Headache |
|
$ |
2,137,000 |
|
|
$ |
2,721,000 |
|
|
$ |
8,656,000 |
|
|
$ |
9,191,000 |
|
Epilepsy |
|
|
3,240,000 |
|
|
|
2,026,000 |
|
|
|
9,929,000 |
|
|
|
10,900,000 |
|
Heart Failure |
|
|
1,620,000 |
|
|
|
702,000 |
|
|
|
4,886,000 |
|
|
|
3,910,000 |
|
Thyroid Deficiency |
|
|
4,787,000 |
|
|
|
1,607,000 |
|
|
|
12,067,000 |
|
|
|
9,708,000 |
|
Other |
|
|
3,953,000 |
|
|
|
547,000 |
|
|
|
9,069,000 |
|
|
|
1,824,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
15,737,000 |
|
|
$ |
7,603,000 |
|
|
$ |
44,607,000 |
|
|
$ |
35,533,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Concentration
of Market and Credit Risk Five of the Companys products, defined as generics
containing the same active ingredient or combination of ingredients, accounted for approximately
21%, 30%, 5%, 8%, and 10%, respectively, of net sales for the three months ended March 31, 2006.
The same five products accounted for 27%, 21%, 15%, 20%, and 10%, respectively, of net sales for
the three months ended March 31, 2005; 23%, 27%, 7%, 12%, 11% of net sales for the nine months
ended March 31, 2006; 31%, 28%, 10%, 16%, and 11%, respectively, of net sales for the nine months
ended March 31, 2005.
Credit terms are offered to customers based on evaluations of the customers financial condition.
Generally, collateral is not required from customers. Accounts receivable payment terms vary and
are stated in the financial statements at amounts due from customers net of an allowance for
doubtful accounts. Accounts outstanding longer than the payment terms are considered past due.
The Company determines its allowance by considering a number
of factors, including the length of time trade accounts receivable are past due, the Companys
previous loss history, the customers current ability to pay its obligation to the Company, and the
condition of the general economy and the industry as a whole. The Company writes-off accounts
receivable when they become uncollectible, and payments subsequently received on such receivables
are credited to the allowance for doubtful accounts.
12
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 supercedes
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 March 31, 2006, the Company had two stock-based employee compensation plans. Prior to July 1,
2005, the Company accounted for those plans under the recognition and measurement provisions of APB
25, and related Interpretations, as permitted by SFAS 123. No stock-based employee compensation
cost was recognized in the Statement of Operations for the year ended June 30, 2005, nor in the
three month or nine month period ended March 31, 2005, as all options granted under those plans had
an exercise price equal to the market value of the underlying common stock on the date of the
grant. Effective July 1, 2005, the Company adopted the fair value recognition provisions of SFAS
123(R), using the modified-prospective-transition method.
The Company adopted an Incentive Stock Option Plan in 2003 (the 2003 plan) that authorized
1,125,000 shares to be reserved. The options generally vest over a three-year period and expire no
later than 10 years from the date of grant.
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 ranges of assumptions were used to compute share-based compensation:
|
|
|
|
|
Risk-free interest rate |
|
|
2.92% 4.5 |
% |
Expected volatility |
|
|
59.46 |
% |
Expected dividend yield |
|
|
0.0 |
% |
Expected life (in years) |
|
|
5.00 |
|
Forfeiture rate |
|
|
3.0 |
% |
Weighted average fair value at date of grant |
|
$ |
2.36 $9.54 |
|
Expected volatility is based on the historical volatility of the price of our common shares
since the date we commenced trading on the AMEX, April 2002. We use historical information to
estimate expected life and forfeitures within the valuation model. The expected term of awards
represents the period of time that options granted are expected to be outstanding. The risk-free
rate for periods within the expected life of the option is based on the U.S. Treasury yield curve
in effect at the time of grant. Compensation cost is recognized using a straight-line method over
the vesting or service period and is net of estimated forfeitures.
The forfeiture rate assumption is the estimated annual rate at which unvested awards will be
forfeited during the next year. This assumption is based on our historical forfeiture rate.
Periodically, management will assess whether it is necessary to adjust the forfeiture 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 following table presents all share-based compensation costs recognized in our statements of
income. All share based compensation expenses are included in S.G.& A:
13
|
|
|
|
|
|
|
|
|
|
|
Nine months ended March 31, |
|
|
2006 |
|
2005 |
|
|
Fair Value |
|
Intrinsic |
Method used to account for share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation under SFAS 123(R) |
|
$ |
1,072,071 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
Tax benefit at effective rate |
|
$ |
238,050 |
|
|
$ |
|
|
The following table illustrates the pro forma effect on net income and earnings per share if
we had recorded compensation expense based on the fair value method for all share-based
compensation awards:
|
|
|
|
|
|
|
|
|
|
|
Nine months ended March 31, |
|
|
|
2006 |
|
|
2005 |
|
Net income (loss) as reported |
|
$ |
4,123,279 |
|
|
$ |
(27,053,752 |
) |
|
|
|
|
|
|
|
|
|
Deduct: total share-based compensation,
determined under fair value based method |
|
|
|
|
|
|
(2,407,795 |
) |
Add: tax benefit at effective rate |
|
|
|
|
|
|
963,118 |
|
|
|
|
|
|
|
|
Net income
(loss) pro forma |
|
$ |
4,123,279 |
|
|
$ |
(28,498,429 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share as reported |
|
$ |
0.17 |
|
|
$ |
(1.12 |
) |
Basic earnings (loss) per share pro forma |
|
$ |
0.17 |
|
|
$ |
(1.18 |
) |
Diluted earnings (loss) per share as reported |
|
$ |
0.17 |
|
|
$ |
(1.12 |
) |
Diluted earnings (loss) per share pro forma |
|
$ |
0.17 |
|
|
$ |
(1.18 |
) |
|
A summary of award activity under the Plans as of March 31, 2006, and changes during the nine
months then ended, is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
Aggregate |
|
Average |
|
|
|
|
|
|
Exercise |
|
Intrinsic |
|
Contractual |
|
|
Awards |
|
Price |
|
Value |
|
Life |
Outstanding at July 1, 2005 |
|
|
857,108 |
|
|
$ |
13.72 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
108,500 |
|
|
|
6.07 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
1,000 |
|
|
|
4.63 |
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2006 |
|
|
964,608 |
|
|
$ |
11.25 |
|
|
$ |
|
|
|
|
7.6 |
|
Outstanding at March 31, 2006 and not yet vested |
|
|
388,721 |
|
|
$ |
11.40 |
|
|
$ |
|
|
|
|
8.0 |
|
Exercisable at March 31, 2006 |
|
|
575,887 |
|
|
$ |
11.14 |
|
|
$ |
|
|
|
|
7.4 |
|
As of March 31, 2006, there was approximately $1,568,000 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.
14
Note 3. New Accounting Standards
In March 2005, the FASB issued FIN 47 Accounting for Conditional Asset Retirement Obligations, an
Interpretation of FASB Statement No. 143. This Interpretation clarifies that a conditional
retirement obligation refers to a legal obligation to perform an asset retirement activity in which
the timing and (or) method of settlement are conditional on a future event that may or may not be
within the control of the entity. The obligation to perform the asset retirement activity is
unconditional even though uncertainty exists about the timing and (or) method of settlement.
Accordingly, an entity is required to recognize a liability for the fair value of a conditional
asset retirement obligation if the fair value of the liability can be reasonably estimated. The
liability should be recognized when incurred, generally upon acquisition, construction or
development of the asset. FIN 47 is effective no later than the end of the fiscal years ending
after December 15, 2005. Our current assessment is that adoption of FIN 47 will have no impact on
our financial statements.
In November 2004, the FASB issued FASB Statement No. 151, Inventory Costs an amendment of ARB
No. 43, Chapter 4 (SFAS No. 151), which is the result of its efforts to converge U.S. accounting
standards for inventories with International Accounting Standards. SFAS No. 151 requires abnormal
amounts of idle facility expense, freight, handling costs and wasted material or spoilage to be
recognized as current-period charges. It also requires that allocation of fixed production
overheads to the costs of conversion be based on the normal capacity of the production facilities.
SFAS No. 151 was effective for inventory costs incurred beginning January 1, 2006. The adoption of
this standard did not have any impact on the Company in the current quarter.
In May 2005, the FASB issued FASB Statement No. 154, Accounting Changes and Error Corrections, a
replacement of APB Opinion No. 20 and FASB Statement No. 3 (SFAS No. 154). Previously, APB Opinion
No. 20, Accounting Changes and FASB Statement No. 3, Reporting Accounting Changes in Interim
Financial Statements required the inclusion of the cumulative effect of changes in accounting
principle in net income of the period of the change. SFAS No. 154 requires companies to recognize a
change in accounting principle, including a change required by a new accounting pronouncement when
the pronouncement does not include specific transition provisions, retrospectively to prior period
financial statements. SFAS No. 154 was effective as of January 1, 2006 and the adoption of this
standard did not have any impact on the Company in the current quarter.
In September 2005, the FASB ratified Emerging Issues Task Force (EITF) Issue No. 04-13, Accounting
for Purchases and Sales of Inventory with the Same Counterparty (EITF 04-13). EITF 04-13 provides
guidance on whether two or more inventory purchase and sales transactions with the same
counterparty should be viewed as a single exchange transaction within the scope of APB No. 29,
Accounting for Nonmonetary Transactions. In addition, EITF 04-13 indicates whether nonmonetary
exchanges of inventory within the same line of business should be recognized at cost or fair value.
EITF 04-13 will be effective as of April 1, 2006 for the Company. The provisions of EITF 04-13 are
applied prospectively. The impact on the Company in periods subsequent to the effective date is
dependent on transactions that could occur in future periods, and therefore cannot be determined
until the transaction occurs.
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 will be effective for the Company on July 1, 2006. The provisions of
FSP No. 46(R)-6 are applied prospectively. The impact on the
15
Company in periods subsequent to the
effective date is dependent on transactions that could occur in future periods, and therefore
cannot be determined until the transaction occurs.
Note 4. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
|
(unaudited) |
|
|
|
|
|
Raw materials |
|
$ |
4,879,880 |
|
|
$ |
5,091,883 |
|
Work-in-process |
|
|
1,871,207 |
|
|
|
1,351,112 |
|
Finished goods |
|
|
4,536,306 |
|
|
|
3,303,478 |
|
Packaging supplies |
|
|
411,869 |
|
|
|
242,296 |
|
|
|
|
|
|
|
|
|
|
$ |
11,699,262 |
|
|
$ |
9,988,769 |
|
|
|
|
|
|
|
|
The preceding amounts are net of inventory reserves of $4,125,000 and $5,300,000 at March 31, 2006
and June 30, 2005, respectively.
Note 5. Property, Plant and Equipment
Property, plant and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mar. 31 |
|
|
June 30, |
|
|
|
Useful Lives |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
(unaudited) |
|
|
|
|
|
Land |
|
|
|
|
|
$ |
233,414 |
|
|
$ |
233,414 |
|
Building and improvements |
|
10 39 years |
|
|
10,366,435 |
|
|
|
9,339,706 |
|
Machinery and equipment |
|
5 10 years |
|
|
15,955,553 |
|
|
|
13,347,416 |
|
Furniture and fixtures |
|
5 7 years |
|
|
826,703 |
|
|
|
825,625 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
27,382,105 |
|
|
$ |
23,746,161 |
|
|
|
|
|
|
|
|
|
|
|
|
Note 6. Investment Securities Available-for-Sale
The amortized cost, gross unrealized gains and losses, and fair value of the Companys
available-for-sale securities are summarized as follows:
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2006 |
|
Available-for-Sale |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
Other Investments |
|
$ |
500,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
500,000 |
|
U.S. Government Agency |
|
|
4,500,720 |
|
|
|
100 |
|
|
|
(112,369 |
) |
|
|
4,388,451 |
|
Mortgage-Backed Securities |
|
|
333,713 |
|
|
|
|
|
|
|
(22,195 |
) |
|
|
311,518 |
|
Asset-Backed Securities |
|
|
393,045 |
|
|
|
|
|
|
|
(8,357 |
) |
|
|
384,688 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,727,478 |
|
|
$ |
100 |
|
|
$ |
(142,921 |
) |
|
$ |
5,584,657 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2005 |
|
Available-for-Sale |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
U.S. Government Agency |
|
$ |
6,582,022 |
|
|
$ |
8,970 |
|
|
$ |
(35,794 |
) |
|
$ |
6,555,198 |
|
Mortgage-Backed Securities |
|
|
363,429 |
|
|
|
|
|
|
|
(10,105 |
) |
|
|
353,324 |
|
Asset-Backed Securities |
|
|
985,246 |
|
|
|
5,361 |
|
|
|
(10,421 |
) |
|
|
980,186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
7,930,697 |
|
|
$ |
14,331 |
|
|
$ |
(56,320 |
) |
|
$ |
7,888,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The amortized cost and fair value of the Companys current available-for-sale securities by
contractual maturity at March 31, 2006 are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
Available for Sale |
|
|
|
Amortized |
|
|
Fair |
|
|
|
Cost |
|
|
Value |
|
Due in one year or less |
|
$ |
410,898 |
|
|
$ |
399,000 |
|
Due after one year through five years |
|
|
3,389,166 |
|
|
|
3,315,632 |
|
Due after five years through ten years |
|
|
361,030 |
|
|
|
353,192 |
|
Due after ten years |
|
|
1,566,384 |
|
|
|
1,516,833 |
|
|
|
|
|
|
|
|
|
|
$ |
5,727,478 |
|
|
$ |
5,584,657 |
|
|
|
|
|
|
|
|
The Company uses the specific identification method to determine the cost of securities sold.
There were no securities held from a single issuer that represented more than 15% of shareholders
equity.
The table below indicates the length of time individual securities have been in a continuous
unrealized loss position as of March 31, 2006:
17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2006 |
|
|
|
|
|
|
|
Less than 12 months |
|
|
12 months or longer |
|
|
Total |
|
Description of |
|
Number of |
|
|
Fair |
|
|
Unrealized |
|
|
Fair |
|
|
Unrealized |
|
|
Fair |
|
|
Unrealized |
|
Securities |
|
Securities |
|
|
Value |
|
|
Loss |
|
|
Value |
|
|
Loss |
|
|
Value |
|
|
Loss |
|
U.S. Government Agency |
|
|
27 |
|
|
|
4,203,554 |
|
|
|
(108,269 |
) |
|
|
122,462 |
|
|
|
(4,100 |
) |
|
|
4,326,016 |
|
|
|
(112,369 |
) |
Mortgage-Backed Securities |
|
|
3 |
|
|
|
311,519 |
|
|
|
(22,195 |
) |
|
|
|
|
|
|
|
|
|
|
311,519 |
|
|
|
(22,195 |
) |
Asset-Backed Securities |
|
|
4 |
|
|
|
384,688 |
|
|
|
(8,357 |
) |
|
|
|
|
|
|
|
|
|
|
384,688 |
|
|
|
(8,357 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total temporarily impaired investment securities |
|
|
34 |
|
|
$ |
4,899,761 |
|
|
$ |
(138,821 |
) |
|
$ |
122,462 |
|
|
$ |
(4,100 |
) |
|
$ |
5,022,223 |
|
|
$ |
(142,921 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 March 31,
2006, there were approximately 34 out of 35 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.
Note 7. Note Receivable
A loan agreement with an API provider (the Borrower) was entered into in July 2005. In the
agreement, the Company loaned the Borrower $2,000,000 to finance general business activities. The
note receivable is secured 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. Borrower
shall 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 shall pay the principal balance
on the loan, plus accrued interest, in twenty four equal consecutive monthly installments beginning
July 2008.
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% (7.50% at March 31, 2006). The line of credit was renewed and
extended to November 30, 2006. At March 31, 2006 and 2005, the Company had $0 outstanding and
$3,000,000 available under the line of credit. The line of credit is collateralized by
substantially all of the Companys assets. The Company currently has no plans to borrow under this
line of credit
Note 9. Unearned Grant Funds
In July 2005, 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 March 31, 2006, the
Company has recognized the grant funding as a short term liability under the caption of Unearned
Grant Funds.
18
Note 10. Long-Term Debt
Long-term debt consists of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
PIDC regional center, LP III loan |
|
$ |
4,500,000 |
|
|
$ |
|
|
Pennsylvania Industrial Development Authority loan |
|
|
1,238,750 |
|
|
|
|
|
Pennsylvania Department of Community & Economic Development loan |
|
|
500,000 |
|
|
|
|
|
Tax-exempt bond loan (PAID) |
|
|
1,154,471 |
|
|
|
1,645,720 |
|
Mortgage loan |
|
|
|
|
|
|
2,700,000 |
|
Equipment loan |
|
|
1,122,916 |
|
|
|
4,486,729 |
|
Construction loan |
|
|
|
|
|
|
699,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total debt |
|
|
8,516,137 |
|
|
|
9,532,448 |
|
Less current portion |
|
|
1,130,706 |
|
|
|
2,269,776 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long term debt |
|
$ |
7,385,431 |
|
|
$ |
7,262,672 |
|
|
|
|
|
|
|
|
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. $4,500,000
was financed 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 $1,238,750 outstanding and as of March 31, 2006, and $68,588
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
March 31, 2006, $86,602 is currently due.
In April 1999, the Company entered into a loan agreement (the Agreement) with a governmental
authority, the Philadelphia Authority for Industrial Development (the Authority or PAID), to
finance future construction and growth projects of the Company. The Authority issued $3,700,000 in
tax-exempt variable rate demand and fixed rate revenue bonds to provide the funds to finance such
growth projects pursuant to a trust indenture (the Trust Indenture). A portion of the Companys
proceeds from the bonds was used to pay for bond issuance costs of approximately $170,000. The
Trust Indenture requires that the Company repay the Authority loan through installment payments
beginning in May 2003 and continuing through May 2014, the year the bonds mature. The bonds bear
interest at the floating variable rate determined by the organization responsible for selling the
bonds (the remarketing agent). The interest rate fluctuates on a weekly basis. The effective
interest rate at March 31, 2006 was 3.32%. At March 31, 2006, the Company has $1,154,471
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
19
secure payment of the
Authority Loan and a portion of the related accrued interest. At March 31, 2006, no portion of the
letter of credit has been utilized.
The Equipment Loan consists of a term loan with a maturity date 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 March 31, 2006, the Company has outstanding $1,122,916 under the Equipment
Loan, of which $320,520 is classified as currently due.
The financing facilities under the 2003 Loan Financing, 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 March 31, 2006, the interest rate for the 2003 Loan Financing (of which only the
Equipment loan remains) was 6.38%.
The Company has executed Security Agreements with Wachovia, PIDA and PIDC in which the Company has
agreed to use substantially all of its assets to collateralize the amounts due.
The terms of the line of credit (see note 8), the PIDC and PIDA financing, the related letter of
credit, and 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 March 31, 2006, the Company has complied with such terms, and successfully met its financial
covenants.
Note 11. Income Taxes
The provision (credit) for federal, state and local income taxes for the three month period ended
March 31, 2006 and 2005 was $856,402 and $(19,438,913), respectively, with effective tax rates of
40.0% and 40.0%, respectively. The provision (credit) for federal, state, and local income taxes
for the nine month period ended March 31, 2006 and 2005 was $2,752,335 and $(18,035,836),
respectively, with effective tax rates of 40.0% and 40.0% 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 operations 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 include 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 (loss) per share follows:
20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
Net Income |
|
|
Shares |
|
|
Net Income (loss) |
|
|
Shares |
|
|
|
(Numerator) |
|
|
(Denominator) |
|
|
(Numerator) |
|
|
(Denominator) |
|
Basic earnings (loss) per share factors |
|
$ |
1,254,659 |
|
|
|
24,135,723 |
|
|
$ |
(29,158,370 |
) |
|
|
24,103,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive stock options |
|
|
|
|
|
|
65,439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per share factors |
|
$ |
1,254,659 |
|
|
|
24,201,162 |
|
|
$ |
(29,158,370 |
) |
|
|
24,103,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share |
|
$ |
0.05 |
|
|
|
|
|
|
$ |
(1.21 |
) |
|
|
|
|
Diluted earnings (loss) per share |
|
$ |
0.05 |
|
|
|
|
|
|
$ |
(1.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended March 31, |
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
|
Net Income |
|
|
Shares |
|
|
Net Income (loss) |
|
|
Shares |
|
|
|
(Numerator) |
|
|
(Denominator) |
|
|
(Numerator) |
|
|
(Denominator) |
|
Basic earnings (loss) per share factors |
|
$ |
4,123,279 |
|
|
|
24,126,588 |
|
|
$ |
(27,053,752 |
) |
|
|
24,092,958 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive stock options |
|
|
|
|
|
|
47,610 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per share factors |
|
$ |
4,123,279 |
|
|
|
24,174,198 |
|
|
$ |
(27,053,752 |
) |
|
|
24,092,958 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share |
|
$ |
0.17 |
|
|
|
|
|
|
$ |
(1.12 |
) |
|
|
|
|
Diluted earnings (loss) per share |
|
$ |
0.17 |
|
|
|
|
|
|
$ |
(1.12 |
) |
|
|
|
|
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 March 31, 2006 and 2005 were 760,358 and
0, respectively. The number of anti-dilutive weighted average shares that have been excluded in
the computation of diluted earnings per share for the nine months ended March 31, 2006 and 2005
were 760,358 and 0, respectively. Because the period prior was in a net loss, none of these shares
were included in the computation of diluted earnings per share as the effect would be
anti-dilutive.
Note 13. Comprehensive Income (Loss)
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 March 31, 2006 and 2005:
21
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended |
|
|
For the nine months ended |
|
COMPREHENSIVE INCOME (LOSS) |
|
3/31/2006 |
|
|
3/31/2005 |
|
|
3/31/2006 |
|
|
3/31/2005 |
|
Other Comprehensive Loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized holding loss on securities |
|
$ |
(19,244 |
) |
|
$ |
(66,421 |
) |
|
$ |
(100,933 |
) |
|
$ |
(71,918 |
) |
Add: Tax savings at effective rate |
|
|
7,698 |
|
|
|
26,568 |
|
|
|
41,533 |
|
|
|
28,767 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total unrealized loss on securities, net |
|
|
(11,546 |
) |
|
|
(39,853 |
) |
|
|
(59,300 |
) |
|
|
(43,151 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive loss |
|
|
(11,546 |
) |
|
|
(39,853 |
) |
|
|
(59,300 |
) |
|
|
(43,151 |
) |
Net income (loss) |
|
|
1,254,659 |
|
|
|
(29,158,370 |
) |
|
|
4,123,279 |
|
|
|
(27,053,752 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) |
|
$ |
1,243,113 |
|
|
$ |
(29,198,223 |
) |
|
$ |
4,063,979 |
|
|
$ |
(27,096,903 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 14. Related Party Transactions
The Company had gross sales of approximately $900,000 and $394,000 during the nine months ended
March 31, 2006 and 2005, respectively, to a distributor (the related party) owned by Jeffrey
Farber, the son of the Chairman of the Board of Directors and principal shareholder of the Company,
William Farber. Accounts receivable includes amounts due from the related party of approximately
$171,000 and $109,000 at March 31, 2006 and 2005, respectively. In managements opinion, the terms
of these transactions were not more favorable to the related party than they would have been to a
non-related party.
Stuart Novick, the son of Marvin Novick, a Director on the Companys Board of Directors through
January 13, 2005, was employed by two insurance brokerage companies (the Insurance Brokers) that
provide insurance agency services to the Company. The Company paid approximately $125,000 and
$495,000 during the nine months ended March 31, 2006 and 2005 to the Insurance Brokers for various
insurance policies. 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 and Chief Executive
Officer of the Company, 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 Suppliers
The Companys primary finished product inventory supplier is Jerome Stevens Pharmaceuticals, Inc.
(JSP), in Bohemia, New York. 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 capsule;
Digoxin tablets; and Levothyroxine Sodium tablets, sold generically and under the brand name
Unithroid®. The term of the agreement is ten years ending on 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 sixty (60) days of notice from the non-breaching party.
22
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 was $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 met the minimum purchase requirement for the
first year of the contract, but there is no guarantee that the Company will be able to continue to
do so in the future. If the Company does not meet the minimum purchase requirements, JSPs sole
remedy is to terminate the agreement.
Under the agreement, JSP is entitled to nominate one person to serve on the Companys Board of
Directors (the Board) provided, however, that the Board shall have the right to reasonably
approve any such nominee in order to fulfill its fiduciary duty by ascertaining that such person 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 March
31, 2006, JSP has not exercised the nomination provision of the agreement. The agreement was
included as an Exhibit in the Current Report on Form 8-K filed by the Company on May 5, 2005, as
subsequently amended.
The following table identifies the purchase commitments with JSP:
|
|
|
|
|
|
|
Commitments with JSP |
|
Less than 1 year |
|
$ |
17,000,000 |
|
13 years |
|
|
37,000,000 |
|
35 years |
|
|
41,000,000 |
|
More than 5 years |
|
|
69,000,000 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
164,000,000 |
|
|
|
|
|
Management determined that the intangible product rights asset created by this agreement was
impaired as of March 31, 2005.
In October 2005, the Company signed an agreement with Orion Pharma (Orion), based in Finland to
purchase and distribute three drug products. Under the terms of the agreement, Orion will supply
Lannett with the finished products and all laboratory documentation and Lannett will coordinate the
completion of the clinical biostudies necessary to submit Abbreviated New Drug Applications
(ANDAs) to the Food and Drug Administration.
In March 2006, the Company signed a multi-part agreement with AZAD Pharma AG to jointly develop and
commercialize one product and entered into a supply agreement for five active pharmaceutical
ingredients.
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 or nine months ended
March 31, 2006 and 2005.
The Company is currently engaged in several civil actions as a co-defendant with many other
manufacturers of Diethylstilbestrol (DES), a synthetic hormone. Prior litigation established that
the Companys pro rata share of any liability is less than one-tenth of one percent. The Company
was represented in many of these actions by the insurance company with which the Company maintained
coverage during the time period that damages were alleged to have occurred. The insurance company
denies coverage for actions alleging involvement of the
23
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.
24
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, 2005.
In addition to historical information, this Form 10-Q contains forward-looking information. The
forward-looking information contained herein is subject to certain risks and uncertainties that
could cause actual results to differ materially from those projected in the forward-looking
statements. Important factors that might cause such a difference include, but are not limited to,
those discussed in the following section entitled Managements Discussion and Analysis of
Financial Condition and Results of Operations. Readers are cautioned not to place undue reliance
on these forward-looking statements, which reflect managements analysis only as of the date of
this Form 10-Q. The Company undertakes no obligation to publicly revise or update these
forward-looking statements to reflect events or circumstances which arise later. Readers should
carefully review the risk factors described in other documents the Corporation files from time to
time with the Securities and Exchange Commission, including the Annual report on Form 10-K filed by
the Company in Fiscal 2005, and any Current Reports on Form 8-K filed by the Company.
In addition to the risks and uncertainties posed generally by the generic drug industry, the
Company faces the following risks and uncertainties:
|
§ |
|
competition from other manufacturers of generic drugs; |
|
|
§ |
|
potential declines in revenues and profits from individual generic pharmaceutical
products due to competitors introductions of their own generic equivalents; |
|
|
§ |
|
new products or treatments by other manufacturers that could render the Companys
products obsolete; |
|
|
§ |
|
the value of the Companys common stock has fluctuated widely in the past, which could
lead to investment losses for shareholders; |
|
|
§ |
|
intense regulation by government agencies may delay the Companys efforts to
commercialize new drug products; and |
|
|
§ |
|
dependence on third parties to supply raw materials and certain finished goods inventory
any failure to obtain a sufficient supply of raw materials from these suppliers could
materially and adversely affect the Companys business. |
Because of the foregoing and other factors, the Company may experience fluctuations in future
operating results on a quarterly or annual basis which could materially adversely affect the
business, financial condition, operating results and the Companys stock price.
25
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.
Stock Options We adopted Statement of Financial Accounting Standards (SFAS) No. 123 (revised
2005), Share-Based Payment, (123(R)) effective July 1, 2005. We applied the standard using the
modified prospective-transition method with no restatement of prior periods. Prior to July 1,
2005, the Company accounted for those plans under the recognition and measurement provisions of APB
25, and related Interpretations, as permitted by SFAS 123. No stock-based employee compensation
cost was recognized in the Statement of Operations for the year ended June 30, 2005, as all options
granted under those plans had an exercise price equal to the market value of the underlying common
stock on the date of the grant.
Since we applied the standard using the modified-prospective-transition-method, 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. Total share-based compensation
expense under SFAS 123(R) was $385,000 and $1,072,000 for the three-month period and nine month
period ended March 31, 2006, respectively. Total compensation cost related to non-vested awards
not yet recognized is $1,568,000 and the weighted average period over which it is to be recognized
is 1.4 years.
Revenue
Recognition The Company recognizes revenue when its products are shipped. At this point,
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 proportionally equal to the
change in sales because of changes in both the product and the customer mix. Increased sales to
wholesalers will generally require additional rebates. Incentives offered to secure sales vary from
product to product. Provisions for estimated rebates and promotional and other credits are
estimated based on historical payment 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.
Chargebacks
The provision for chargebacks is the most significant and complex estimate used in
the recognition of revenue. The Company sells its products directly to wholesale distributors,
generic distributors, retail pharmacy chains and mail-order pharmacies. The Company also sells its
products indirectly to independent pharmacies, managed care organizations, hospitals, nursing
homes, and group purchasing organizations, collectively referred to as indirect customers.
Lannett enters into agreements with its indirect customers to establish pricing for certain
products. The indirect customers then independently select a wholesaler from which
26
to actually purchase the products at these agreed-upon prices. Lannett will provide credit to the
wholesaler for the difference between the agreed-upon 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. This credit is called a chargeback. The provision for chargebacks is
based on expected sell-through levels by the Companys wholesale customers to the indirect
customers, and estimated wholesaler inventory levels. As sales to the large wholesale customers,
such as Cardinal Health, AmerisourceBergen, and McKesson, increase, the reserve for chargebacks
will also generally increase. However, the size of the increase depends on the product mix. The
Company continually monitors the reserve for chargebacks and makes adjustments when management
believes that actual chargebacks may differ from estimated reserves.
Rebates
Rebates are offered to the Companys key customers to promote customer loyalty and
encourage greater product sales. These rebate programs provide customers with rebate credits upon
attainment of pre-established volumes or attainment of net sales milestones for a specified period.
Other promotional programs are 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
select 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 pre-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. The reserve for returns has returned
to historical norms after a prior year one time adjustment for the anticipation of a large return
concerning Levothyroxine. The prior year return reserve was $1.25 million of which most has been
returned. 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 nine months ended March 31, 2006 and 2005:
27
For the nine months ended
March 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 Fiscal
2005 |
|
|
(7,720,000 |
) |
|
|
(1,450,900 |
) |
|
|
(1,264,800 |
) |
|
|
(27,200 |
) |
|
|
(10,462,900 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual Credits Issued-Related
To Sales Recorded in Fiscal
2006 |
|
|
(8,612,100 |
) |
|
|
(2,313,400 |
) |
|
|
(273,400 |
) |
|
|
(892,800 |
) |
|
|
(12,091,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional Reserves Charged to
Net Sales During Fiscal 2006 |
|
|
21,207,000 |
|
|
|
4,085,800 |
|
|
|
297,300 |
|
|
|
912,700 |
|
|
|
26,502,800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Balance as of March
31, 2006 |
|
$ |
12,874,600 |
|
|
$ |
1,350,300 |
|
|
$ |
451,100 |
|
|
$ |
22,200 |
|
|
$ |
14,698,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the nine months ended
March 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Category |
|
Chargebacks |
|
|
Rebates |
|
|
Returns |
|
|
Other |
|
|
Total |
|
Reserve Balance as of June 30,
2004 |
|
$ |
6,484,500 |
|
|
$ |
1,864,200 |
|
|
$ |
448,000 |
|
|
$ |
88,300 |
|
|
$ |
8,885,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual Credits Issued-Related
To Sales Recorded in Fiscal 2004 |
|
|
(4,966,500 |
) |
|
|
(1,936,500 |
) |
|
|
(408,400 |
) |
|
|
(87,000 |
) |
|
|
(7,398,400 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual Credits Issued-Related
To Sales Recorded in Fiscal 2005 |
|
|
(8,494,900 |
) |
|
|
(4,455,300 |
) |
|
|
(736,500 |
) |
|
|
(425,800 |
) |
|
|
(14,112,500 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional Reserves Charged to
Net Sales During Fiscal 2005 |
|
|
14,559,400 |
|
|
|
6,696,800 |
|
|
|
971,900 |
|
|
|
472,800 |
|
|
|
22,700,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reserve Balance as of March 31,
2005 |
|
$ |
7,582,500 |
|
|
$ |
2,169,200 |
|
|
$ |
275,000 |
|
|
$ |
48,300 |
|
|
$ |
10,075,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The chargeback reserve increased to $12,874,600 at March 31, 2006 due to an increased level of
chargebacks, as a percentage of sales, required by the wholesale distributor market. In many
cases, the increasingly competitive generic pharmaceutical market has resulted in decreased prices
to Lannett customers. This competitive environment resulted in increased chargeback reserves. The
increase in the rebate reserve to $1,350,300 at March 31, 2006 from $1,028,800 at June 30, 2005 is
related to the increase in sales for the quarter then ended.
The reserved amount at June 30, 2005 compared to actual credits issued on prior sales has a
remaining balance of $287,000. This is due in part to our return policy which allows customers up
to 6 months past expiration to return items as well as a small amount of customer inventory gone
unsold. The difference in the reserve for rebates and the actual rebates as well as the return
difference is additional rebates were offered to offset future returns.
The Company ships its products to the warehouses of its wholesale and retail chain customers. When
the Company and a customer come to an agreement for the supply of a product, the customer will
generally continue to purchase the product, stock its warehouse(s), and resell the product to its
own customers. The Companys customer will continually reorder the product as its warehouse is
depleted. The Company generally has no
28
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 Companys products have from 18 months to 36 months of shelf-life at the time of
manufacture. The Company monitors its customers purchasing trends to attempt 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 customers.
The products that the Company sells are generic versions of brand named drugs. The consumer
markets for such drugs are well-established markets with many years of historically-confirmed
consumer demand. Such consumer demand may be affected by several factors, including alternative
treatments, cost, etc. However, the effects of changes in such consumer demand for the Companys
products, like generic products manufactured by other generic companies, are gradual in nature.
Any overall decrease in consumer demand for generic products generally occurs over an extended
period of time. This is because there are thousands of doctors, prescribers, third-party payers,
institutional formularies and other buyers of drugs that must change prescribing habits and
medicinal practices before such a decrease would affect a generic drug market. 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.
Accounts
Receivable The Company performs ongoing 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 current 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.
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.
29
Results of Operations Three months ended March 31, 2006 compared with three months ended
March 31, 2005
Net sales increased 107% from $7,603,000 for the three months ended March 31, 2005 (Third Quarter
Fiscal 2005) to $15,737,000 for the three months ended March 31, 2006 (Third Quarter Fiscal
2006). The primary result was due to decreased price pressure from a year ago and new product
sales of $3,100,000. Year over year increase in existing product sales were a result of volume
increases of 42% and price increases of 24%.
The table below identifies the Companys approximate net sales to each category for the three
months ended March 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
For the three months ended |
|
Customer Category |
|
3/31/2006 |
|
|
3/31/2005 |
|
Wholesaler/Distributor |
|
$ |
12,256,000 |
|
|
$ |
4,141,000 |
|
Retail Chain |
|
|
1,521,000 |
|
|
|
1,712,000 |
|
Mail-Order Pharmacy |
|
|
1,589,000 |
|
|
|
1,000,000 |
|
Private Label |
|
|
371,000 |
|
|
|
750,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
15,737,000 |
|
|
$ |
7,603,000 |
|
Cost of sales increased 120% from $4,267,000 for the Third Quarter Fiscal 2005 to $9,404,000 for
the Third Quarter Fiscal 2006. The increase in cost of sales is due to an increase in direct
variable costs such as raw materials and costs of finished goods as a result of increased volume.
Gross profit margins for the Third Quarter Fiscal 2006 and the Third Quarter Fiscal 2005 were 40%
and 44%, respectively. Cost of Sales and gross margin discussed here excludes amortization of
intangible assets. The Company anticipates gross profit margins to remain stable for the
foreseeable future.
Research and development (R&D) expenses increased 7% from $1,173,000 for the Third Quarter Fiscal
2005 to $1,252,000 for the Third Quarter Fiscal 2006. The increase is primarily due to an increase
in the number of ongoing product development projects as well generic bioequivalence tests which
are commonly required for ANDA submissions. R&D costs represent spending on products in the
pipeline. Current spending is anticipated to benefit the continued growth of the Companys product
mix.
Selling, general and administrative expenses decreased 13% from $2,931,000 for the Third Quarter
Fiscal 2005 to $2,555,000 for the Third Quarter Fiscal 2006. The decrease is due to fewer costs
associated with the first year of Sarbanes Oxley compliance and the elimination of professional
fees incurred in the Third Quarter Fiscal 2005 to perform analysis on the impairment of the
Companys intangible assets. The savings were somewhat offset by the adoption of SFAS 123(R) which
totaled $385,000 for the quarter ending March 31, 2006.
Amortization expense for the intangible asset for the three months ended March 31, 2006 and 2005
was approximately $446,000 and $1,690,000, respectively. The amortization expense relates to the
March 23, 2005 exclusive marketing and distribution rights agreement with JSP. The reduction of
this expense is due entirely to the impairment of the intangible assets recorded in the Third
Quarter Fiscal 2005.
In fiscal year 2005 management believed that events (as described below) occurred which indicated
that the carrying value of the intangible asset was not recoverable. In accordance with Statement
of Financial Accounting Standards No. 144 (FAS 144), Accounting for the Impairment or Disposal of
Long-Lived Assets, the Company engaged a third party valuation specialist to assist in the
performance of an impairment test for the quarter ended
30
March 31, 2005. The impairment test was performed by discounting forecasted future net cash flows
for the JSP products covered under the agreement and then comparing the discounted present value of
those cash flows to the carrying value of the asset (inclusive of the $1.5 million payable to JSP
for the Third AB rating). As a result of the testing, the Company has determined that the
intangible asset was impaired as of March 31, 2005. In accordance with FAS 144, the Company
recorded a non-cash impairment loss of approximately $46,093,000 to write the asset down to its
fair value of approximately $16,062,000 as of March 31, 2005. This impairment loss is shown on the
statement of operations as a component of operating loss.
Management believes that several factors contributed to the impairment of this asset. In December
2005, the Levothyroxine Sodium tablet product received the AB rating to Synthroid®. The expected
sales increase as a result of the AB rating did not occur in the third quarter of 2005. The delay
in receiving the AB rating to Synthroid® caused the Company to be competitively disadvantaged with
its Levothyroxine Sodium tablet product and to lose market share to competitors whose products had
already received AB ratings to both major brand thyroid deficiency drugs. Additionally, the
generic market for thyroid deficiency drugs turned out to be smaller than it was anticipated to be
as a result of a lower brand-to-generic substitution rate. Increased competition in the generic
drug market, both from existing competitors and new entrants, has resulted in significant pricing
pressure on other products supplied by JSP. The combination of these factors has resulted in
diminished forecasted future net cash flows which, when discounted, yield a lower present value
than the carrying value of the asset before impairment.
For the remaining nine years of the contract, the Company will incur annual amortization expense of
approximately $1,785,000.
As a result of the items discussed above, the Companys financial results increased from an
operating loss of $48,551,000 in the Third Quarter Fiscal 2005 to an operating income of $2,080,000
in the Third Quarter of Fiscal 2006.
The Companys interest expense decreased slightly from approximately $96,000 in the Third Quarter
Fiscal 2005 to approximately $55,000 in the Third Quarter Fiscal 2006 as a result of the
refinancing. Interest income increased from approximately $51,000 in the Third Quarter Fiscal 2005
to approximately $96,000 in the Third Quarter Fiscal 2006, as a result of increasing investments of
excess cash in marketable securities.
The Companys income tax benefit decreased from $19,439,000 in the Third Quarter Fiscal 2005 to a
tax expense of $856,000 in the Third Quarter Fiscal 2006 as a result of the Companys increased
operating income. The effective tax rate held steady at 41% in the Third Quarter Fiscal 2005 to
Third Quarter of 2006.
The Company reported a net loss of $29,158,000 in the Third Quarter Fiscal 2005, or $1.21 basic and
diluted loss per share, compared to net income of $1,255,000 in the Third Quarter Fiscal 2006, or
$0.05 basic and diluted income per share.
Results of Operations Nine months ended March 31 ,2006 compared with nine months ended March
31, 2005
Net sales increased 26% from $35,533,000 for the nine months ended March 31, 2005 to $44,607,000
for the nine months ended March 31, 2006. The increase was primarily due to new products introduced
in the second and third quarters in combination with better sales across a wider mix of drugs.
Overall, new product sales contributed $7,800,000 to the sales in the current year, across a broad
variety of medical indications. The year over year increase in existing product sales was a result
of volume declines of 2% and price increases of 5%.
The table below identifies the Companys approximate net sales to each category for the nine months
ended March 31, 2006 and 2005:
31
|
|
|
|
|
|
|
|
|
|
|
For the nine months ended |
|
Customer Category |
|
3/31/2006 |
|
|
3/31/2005 |
|
Wholesaler/Distributor |
|
$ |
30,495,000 |
|
|
$ |
22,880,000 |
|
Retail Chain |
|
|
6,979,000 |
|
|
|
6,993,000 |
|
Mail-Order Pharmacy |
|
|
5,094,000 |
|
|
|
3,511,000 |
|
Private Label |
|
|
2,039,000 |
|
|
|
2,149,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
44,607,000 |
|
|
$ |
35,533,000 |
|
Cost of sales increased 28% from $18,973,000 for the nine months ended March 31, 2005 to
$24,331,000 for the nine months ended March 31, 2006. The
increase is attributable to increases
in sales volume. Gross profit margins for the nine months ended March 31, 2005 and the nine months
ended March 31, 2006 were 47% and 45%, respectively. Cost of Sales and gross margin discussed here
excludes amortization of intangible assets. The Company anticipates gross profit margins to remain
stable for the foreseeable future.
Research and development (R&D) expenses increased 37% from $3,522,000 for the nine months ended
March 31, 2005 to $4,814,000 for the nine months ended March 31, 2006. The increase is primarily
due to the Companys effort to increase the number of product development projects. R&D costs
represent spending on products in the pipeline. Current spending is anticipated to benefit the
continued growth of the Companys product mix.
Selling, general and administrative expenses increased 8% from $6,817,000 for the nine months ended
March 31, 2005 to $7,332,000 for the nine months ended March 31, 2006. The increase is primarily
due to the adoption of SFAS 123(R) which contributed stock compensation expense of $1,072,000.
Depreciation expense increased $272,000 compared to the prior year.
Amortization expense for the intangible asset for the nine months ended March 31, 2006 and 2005 was
approximately $1,339,000 and $5,070,000, respectively. The amortization expense relates to the
March 23, 2005 exclusive marketing and distribution rights agreement with JSP. The reduction of
this expense is due entirely to the impairment of the intangible assets recorded in the Third
Quarter Fiscal 2005.
In fiscal year 2005, management believed that events (as described below) occurred which indicated
that the carrying value of the intangible asset was not recoverable. In accordance with Statement
of Financial Accounting Standards No. 144 (FAS 144), Accounting for the Impairment or Disposal of
Long-Lived Assets, the Company engaged a third party valuation specialist to assist in the
performance of an impairment test for the quarter ended March 31, 2005. The impairment test was
performed by discounting forecasted future net cash flows for the JSP products covered under the
agreement and then comparing the discounted present value of those cash flows to the carrying value
of the asset (inclusive of the $1.5 million payable to JSP for the Third AB rating). As a result
of the testing, the Company has determined that the intangible asset was impaired as of March 31,
2005. In accordance with FAS 144, the Company recorded a non-cash impairment loss of approximately
$46,093,000 to write the asset down to its fair value of approximately $16,062,000 as of March 31,
2005. This impairment loss is shown on the statement of operations as a component of operating
loss.
Management believes that several factors contributed to the impairment of this asset. In December
2005, the Levothyroxine Sodium tablet product received the AB rating to Synthroid®. The expected
sales increase as a result of the AB rating did not occur in the third quarter of 2005. The delay
in receiving the AB rating to Synthroid® caused the Company to be competitively disadvantaged with
its Levothyroxine Sodium tablet product and to lose market share to competitors whose products had
already received AB ratings to both major brand thyroid deficiency drugs. Additionally, the
generic market for thyroid deficiency drugs turned out to be smaller than it was anticipated to be
as a result of a lower brand-to-generic substitution rate. Increased
32
competition in the generic drug market, both from existing competitors and new entrants, has
resulted in significant pricing pressure on other products supplied by JSP. The combination of
these factors has resulted in diminished forecasted future net cash flows which, when discounted,
yield a lower present value than the carrying value of the asset before impairment.
For the remaining nine years of the contract, the Company will incur annual amortization expense of
approximately $1,785,000.
As a result of the items discussed above, the Companys financial results increased from an
operating loss of $44,942,000 in the nine months ended March 31, 2005 to an operating income of
$6,792,000 in the nine months ended March 31, 2006.
The Companys interest expense increased from approximately $245,000 in the nine months ended March
31, 2005 to approximately $247,000 in the nine months ended March 31, 2006 primarily as a result of
an increase in the Prime Rate and LIBOR rate which the variable rates of the Construction and
Equipment loans depend offset by the refinancing in December 2005. Interest income increased from
approximately $99,000 in the nine months ended March 31, 2006 to approximately $334,000 in the nine
months ended March 31, 2006, as a result of increasing investments of excess cash in marketable
securities.
The Companys income tax classification changed from an income tax benefit of $18,036,000 for the
nine months ended March 31, 2005 to an income tax expense of $2,752,000 in the nine months ended
March 31, 2006 as a result of the Companys increased operating income. The effective tax rate
held steady at 40% in the nine months ended March 31, 2005 to nine months ended March 31, 2006.
The Company reported net income of $4,123,000 in the nine months ended March 31, 2006, or $0.17
basic and diluted income per share, compared to a net loss of $27,054,000 in the nine months ended
March 31, 2005, or $1.12 basic and diluted loss per share.
The Company regularly monitors customer Accounts Receivable (AR) balances, as it and others in the
industry may experience significant fluctuations in balances due from customers. The primary
benchmark for evaluating the receivable balances is a calculation called Days Sales in Accounts
Receivable. This calculation takes the Net AR and subtracts the Rebates and Chargeback reserve.
This total is then divided by the average daily sales for the period. The table below shows how
the Company has calculated this item for the most recent periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3/31/05 |
|
6/30/05 |
|
3/31/06 |
Trade Accounts
Receivable |
|
|
8,663,377 |
|
|
$ |
10,735,529 |
|
|
$ |
23,664,023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rebates and
chargebacks accrual |
|
|
10,075,000 |
|
|
|
10,750,000 |
|
|
|
14,698,211 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Sales |
|
|
35,533,206 |
|
|
|
44,901,645 |
|
|
|
44,607,481 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Daily Sales |
|
|
129,683 |
|
|
|
123,018 |
|
|
|
162,801 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Days Sales in AR |
|
|
-10.9 |
|
|
|
-0.1 |
|
|
|
55.1 |
|
The Companys credit terms are consistent with the industry at 60 days for payment from customers
and wholesalers. As can be seen in the above table, the Days Sales calculation amounts to less
than zero at March 31, 2005 and June 30, 2005. This is a result of a few significant wholesaler
customers with balances near zero or with credit balances. When an active customer has a zero
balance, it is due to the inability of the customer to
33
resell Lannetts products within 60 days. At that point, the wholesaler is required to remit to
Lannett the full balance due. Subsequent chargebacks will cause the net AR balance to decline even
further, until the wholesaler sells the product and requests actual chargebacks. At March 31, 2005
and June 30, 2005, the product Levothyroxine Sodium tablets were selling at a slower pace than
anticipated by the Companys wholesale customers due to a delay in the AB rating. The Company
believes this was a one-time event and does not expect a similar situation in the future. A number
of wholesaler customers had paid the full balances due, and had not sold the product to end-user
customers, and thus did not yet claim any chargebacks until after June 30, 2005. At March 31,
2006, Days Sales calculation has returned to a number that indicates payments by wholesalers and
other customers are more closely matching the sales less chargebacks for the period. Currently, no
customer has a credit balance. This is due to improved sales of Levothyroxine Sodium tablets by
the wholesalers for the fiscal year 2006.
Liquidity and Capital Resources
Net cash provided by operating activities of $2,255,009 for the nine months ended March 31, 2006
was attributable to net income of $4,123,279, as adjusted for the effects of non-cash items of
$3,990,602 and a net increase in operating assets and liabilities of $5,858,872. Significant
changes in operating assets and liabilities are comprised of:
|
1. |
|
An increase in trade accounts receivable of $8,980,283 due to a continued
growth in gross sales in the months of February and March. |
|
|
2. |
|
An increase in inventories of $1,710,493 is due to a general increase in
products offered. Also, in anticipation of newer product sales, inventory is building
up. |
|
|
3. |
|
A decrease in prepaid taxes of $2,756,561 is attributable to estimated tax
payments on net income that offsets previous tax payments that were made during Fiscal
2005 while in a net loss position. |
|
|
4. |
|
An increase in accrued expenses of $2,199,501 due in part to a timing
difference in the receipt of large inventory purchases. It is also attributable to a
performance based bonus, payable annually. |
The net cash used in investing activities of $3,789,101 for the nine months ended March 31, 2006
was attributable to the Companys purchase of a $2,000,000 note receivable and $4,033,852 in
capital expenditures to expand production and R&D space. 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 net cash used in financing activities of $901,583 for the nine months ended March 31, 2006 was
attributed to the Companys refinancing efforts to gain more favorable percentage rates as well as
move more debt long term.
The following table summarizes the remaining repayments of debt, including sinking fund
requirements as of March 31, 2006 for the subsequent twelve month periods:
|
|
|
|
|
|
|
Amounts Payable |
|
Twelve Month Periods |
|
to Institutions |
|
2006 |
|
$ |
1,130,706 |
|
2007 |
|
|
987,487 |
|
2008 |
|
|
492,677 |
|
2009 |
|
|
338,309 |
|
2010 |
|
|
4,681,880 |
|
Thereafter |
|
|
885,078 |
|
|
|
|
|
|
|
$ |
8,516,137 |
|
|
|
|
|
34
The Company has no material leases, commitments, or contractual obligations other than the JSP
commitment that is disclosed in Note 15, Material Contract with Suppliers.
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% (7.50% at March 31, 2006). The line of credit was renewed and
extended to November 30, 2006. At March 31, 2006 and 2005, the Company had $0 outstanding and
$3,000,000 available 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, the 2003 Loan
Financing, and the new PIDC/PIDA loan agreements require that the Company meet certain financial
covenants and reporting standards, including the attainment of standard financial liquidity and net
worth ratios. As of March 31, 2006, the Company has complied with such terms, and successfully met
its financial covenants.
In July 2005, the Company received $500,000 of grant funding from the Commonwealth of Pennsylvania,
acting through the Department of Community and Economic Development. The grant funding program
requires the Company to use the funds for machinery and equipment located at their Pennsylvania
locations, hire an additional 100 full-time employees by June 30, 2006, operate its Pennsylvania
locations a minimum of five years and meet certain matching investment requirements. If the
Company fails to comply with any of the requirements above, the Company would be liable to the full
amount of the grant funding ($500,000). The Company records the unearned grant funds as a
liability until the Company complies with all of the requirements of the grant funding program. On
a quarterly basis, the Company will monitor its progress in fulfilling the requirements of the
grant funding program and will determine the status of the liability. As of March 31, 2006, the
Company has recognized the grant funding as a current liability under the caption of Unearned Grant
Funds.
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, 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. 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. 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.
35
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
an outside firm 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 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 compliment the progress of its own internal R&D efforts.
Occasionally the Company will work on developing a drug product that does not require FDA approval.
The FDA allows generic manufacturers to manufacture and sell products which are equivalent to
innovator drugs which are grand-fathered, under FDA rules, prior to the passage of the Hatch-Waxman
Act of 1984. The FDA allows generic manufacturers to produce and sell generic versions of such
grand-fathered products by simply performing and internally documenting the products stability
over a period of time. Under this scenario, a generic company can forego the time required for FDA
ANDA approval.
The Company has also contracted with Spectrum Pharmaceuticals Inc., based in California, to market
generic products developed and manufactured by Spectrum and/or its partners. The first applicable
product under this agreement is ciprofloxacin tablets, the generic version of Cipro ®, an
anti-bacterial drug, marketed by Bayer Corporation, prescribed to treat infections. The Company
has also initiated discussions with UniChem, of India, and Orion Pharma, of Finland, 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. Management believes the future spending on product
development, including bio equivalency studies, will likely increase in future periods. Hence, the
Company does not believe that its outside contracts for product development and manufacturing
supply, including Spectrum Pharmaceuticals Inc., 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.
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 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.
36
PART I. FINANCIAL INFORMATION
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 nine months ended March 31, 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.
37
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.
PART II. OTHER INFORMATION
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. |
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: May 9, 2006
|
|
By: |
|
/s/ Brian Kearns |
|
|
|
|
|
|
|
|
|
Brian Kearns |
|
|
|
|
Vice President of Finance, Treasurer and |
|
|
|
|
Chief Financial Officer |
|
|
|
|
|
|
|
By: |
|
/s/ Arthur P. Bedrosian |
|
|
|
|
|
|
|
|
|
Arthur P. Bedrosian |
|
|
|
|
President and Chief Executive Officer |
38
Exhibit Index
|
|
|
|
|
|
|
|
|
31.1
|
|
Certification of Chief Executive
Officer Pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
|
|
Filed Herewith
|
|
|
40 |
|
|
|
|
|
|
|
|
|
|
31.2
|
|
Certification of Chief Financial
Officer Pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
|
|
Filed Herewith
|
|
|
41 |
|
|
|
|
|
|
|
|
|
|
32
|
|
Certifications of Chief Executive
Officer and Chief Financial Officer
Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
|
Filed Herewith
|
|
|
42 |
|
39