UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q/A

 

x                              QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED DECEMBER 31, 2006.

 

o                                 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM                  TO                 .

 

Commission File No. 001-31298

 

LANNETT COMPANY, INC.

(Exact Name of Registrant as Specified in its Charter)

 

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   x                                 No o

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

Yes   x                                 No 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 x

 

As of September 21, 2007, there were 24,177,118 shares of the issuer’s common stock, $.001 par value, outstanding.

 

 



 

EXPLANATORY NOTE

 

This amendment on Form 10-Q/A (the “Amendment”) amends and restates Lannett Company Inc.’s quarterly report on Form 10-Q for the three months and six months ended December 31, 2006, as initially filed with the Securities and Exchange Commission on February 7, 2007 (the “Form 10-Q”).

 

The restatement is the result of an error identified in the fourth quarter of Fiscal 2007, which affected the first, second and third quarters of Fiscal 2007. We identified a number of production orders that were completed and removed from production in our information system during Fiscal 2007, but for which the month-end process to reduce the work in process (WIP) balance and expense the activity to cost of goods  sold (COGS) in the general ledger did not occur. The result was that work in process inventory was overstated and cost of goods sold was understated by $840,000 as of and for the year ended June 30, 2007, with the following quarterly pre tax accounting effect of the misstatement as follows: three months ended September 30, 2006 was $394,000; three months ended December 31, 2006 was $158,000; and three months ended March 31, 2007 was $95,000. For further details, refer to Note 2 and Item 4.

 

Another error was identified in the fourth quarter of Fiscal 2007, resulting from the calculation of stock-based compensation expense. It also affected the first, second and third quarters of Fiscal 2007. We identified in the fourth quarter of Fiscal 2007 that the estimated life of stock options was calculated using the incorrect terms for valuing stock. The result was that stock compensation expense was misstated in each quarter of Fiscal 2007. The three quarters amounted to an overstatement of $52,000 combined.  For further details refer to Note 2 and Item 4.

 

1



 

Table of Contents

 

PART I. FINANCIAL INFORMATION

 

 

 

ITEM 1.

FINANCIAL STATEMENTS

 

 

 

 

 

Consolidated Balance Sheets (unaudited)
as of December 31, 2006 (restated) and June 30, 2006

 

 

 

 

 

Consolidated Statements of Income (unaudited)
for the three months and six months ended December 31, 2006 (restated) and 2005

 

 

 

 

 

Consolidated Statement of Changes in Shareholders’ Equity (unaudited)
for the six months ended December 31, 2006 (restated)

 

 

 

 

 

Consolidated Statements of Cash Flows (unaudited)
for the six months ended December 31, 2006 (restated) and 2005

 

 

 

 

 

Notes to Consolidated Financial Statements (unaudited) (restated)

 

 

 

 

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

 

 

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

 

 

 

ITEM 4.

CONTROLS AND PROCEDURES

 

 

 

 

PART II. OTHER INFORMATION

 

 

 

ITEM 1.

LEGAL PROCEEDINGS

 

 

 

 

ITEM 6.

EXHIBITS AND REPORTS ON FORM 8-K

 

 

 

 

CERTIFICATION OF PRESIDENT & CHIEF EXECUTIVE OFFICER

 

 

 

CERTIFICATION OF VICE PRESIDENT OF FINANCE, TREASURER & CHIEF FINANCIAL OFFICER

 

 

 

CERTIFICATION PURSUANT TO SECTION 906 OF SARBANES OXLEY ACT OF 2002

 

 

2



 

PART I. FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

LANNETT COMPANY, INC. AND SUBSIDIARIES

 

CONSOLIDATED BALANCE SHEETS

 

 

 

December 31, 2006

 

June 30, 2006

 

 

 

(unaudited)

 

 

 

 

 

(restated, see Note 2)

 

 

 

ASSETS

 

 

 

 

 

Current Assets

 

 

 

 

 

Cash

 

$

2,006,530

 

$

468,359

 

Trade accounts receivable (net of allowance of $250,000 for both periods)

 

27,171,392

 

24,921,671

 

Inventories

 

8,933,026

 

11,476,503

 

Investments AFS - curr. portion

 

 

 

 

Interest receivable

 

100,285

 

193,549

 

Prepaid taxes

 

2,195,782

 

3,212,511

 

Deferred tax assets - current portion

 

1,461,172

 

1,461,172

 

Other current assets

 

1,771,122

 

1,753,082

 

Total Current Assets

 

43,639,309

 

43,486,847

 

 

 

 

 

 

 

Property, plant, and equipment

 

31,015,842

 

28,782,350

 

Less accumulated depreciation

 

(10,344,231

)

(9,136,801

)

 

 

20,671,611

 

19,645,549

 

 

 

 

 

 

 

Construction in progress

 

705,203

 

1,955,508

 

Investment securities - available for sale

 

3,771,518

 

5,621,609

 

Note receivable

 

8,529,163

 

3,182,498

 

Intangible asset (product rights) - net of accumulated amortization

 

12,938,835

 

13,831,168

 

Deferred tax asset

 

16,549,009

 

18,070,674

 

Other assets

 

240,746

 

198,211

 

TOTAL ASSETS

 

$

107,045,394

 

$

105,992,064

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

LIABILITIES

 

 

 

 

 

Current Liabilities

 

 

 

 

 

Accounts payable

 

$

4,609,938

 

$

763,744

 

Accrued expenses

 

4,262,256

 

5,217,894

 

Unearned grant funds

 

500,000

 

500,000

 

Current portion of long term debt

 

591,775

 

546,886

 

Rebates and chargebacks payable

 

8,558,558

 

13,012,084

 

Total Current Liabilities

 

18,522,527

 

20,040,608

 

 

 

 

 

 

 

Long term debt, less current portion

 

7,349,491

 

7,649,806

 

Deferred tax liability

 

2,545,734

 

2,545,734

 

TOTAL LIABILITIES

 

28,417,752

 

30,236,148

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

 

 

 

SHAREHOLDERS’ EQUITY

 

 

 

 

 

Common stock - authorized 50,000,000 shares, par value $0.001; issued and outstanding, 24,154,749 and 24,141,325 shares, respectively

 

24,154

 

24,141

 

Additional paid in capital

 

72,327,719

 

71,742,402

 

Retained earnings

 

6,709,585

 

4,456,387

 

Accumulated other comprehensive loss

 

(39,246

)

(72,444

)

 

 

79,022,212

 

76,150,486

 

Less: Treasury stock at cost - 50,900 shares

 

(394,570

)

(394,570

)

TOTAL SHAREHOLDERS’ EQUITY

 

78,627,642

 

75,755,916

 

TOTAL LIABILITIES AND SHAREHOLDER'S EQUITY

 

$

107,045,394

 

$

105,992,064

 

 

The accompanying notes to consolidated financial statements are an integral part of these statements.

 

3



 

LANNETT COMPANY, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF INCOME

 

(UNAUDITED)

 

 

 

Three months ended
December 31,

 

Six months ended
December 31,

 

 

 

2006

 

2005

 

2006

 

2005

 

 

 

(restated, see Note 2)

 

 

 

(restated, see Note 2)

 

 

 

Net sales

 

$

22,916,347

 

$

15,228,767

 

$

44,884,171

 

$

28,870,299

 

Cost of sales (excluding amortization of intangible asset)

 

17,402,285

 

8,063,974

 

30,642,680

 

14,926,759

 

Gross profit

 

5,514,062

 

7,164,793

 

14,241,491

 

13,943,540

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

1,538,108

 

2,420,977

 

3,316,534

 

3,562,077

 

Selling, general, & administrative expenses

 

1,981,664

 

2,204,916

 

6,353,241

 

4,782,051

 

Amortization of intangible assets

 

446,166

 

446,167

 

892,332

 

892,333

 

Operating income

 

1,548,124

 

2,092,733

 

3,679,384

 

4,707,079

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest expense

 

(68,369

)

(85,441

)

(132,393

)

(193,444

)

Interest income

 

112,197

 

99,300

 

210,805

 

247,349

 

 

 

43,828

 

13,859

 

78,412

 

53,905

 

 

 

 

 

 

 

 

 

 

 

Income before income tax expense

 

1,591,952

 

2,106,592

 

3,757,796

 

4,760,984

 

Income tax expense

 

636,781

 

842,518

 

1,504,598

 

1,895,933

 

Net income

 

$

955,171

 

$

1,264,074

 

$

2,253,198

 

$

2,865,051

 

 

 

 

 

 

 

 

 

 

 

Basic earnings per share

 

$

0.04

 

$

0.05

 

$

0.09

 

$

0.12

 

Diluted earnings per share

 

$

0.04

 

$

0.05

 

$

0.09

 

$

0.12

 

 

 

 

 

 

 

 

 

 

 

Basic weighted average number of shares

 

24,154,553

 

24,125,884

 

24,151,237

 

24,122,181

 

Diluted weighted average number of shares

 

24,222,515

 

24,151,222

 

24,197,946

 

24,140,863

 

 

The accompanying notes to consolidated financial statements are an integral part of these statements.

 

4



 

LANNETT COMPANY, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS’ EQUITY

 

(UNAUDITED)

 

 

 

Common Stock

 

Additional Paid-

 

Retained

 

Treasury

 

Accumulated Other
Comprehensive Loss,

 

Total
Shareholders’

 

 

 

Shares

 

Amount

 

in Capital

 

Earnings

 

Stock

 

net

 

Equity

 

 

 

 

 

 

 

(restated)

 

(restated)

 

 

 

 

 

(restated)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2006

 

24,141,325

 

$

24,141

 

$

71,742,402

 

$

4,456,387

 

$

(394,570

)

$

(72,444

)

$

75,755,916

 

Shares issued in connection with employee stock purchase plan

 

13,424

 

13

 

61,270

 

 

 

 

 

 

 

61,283

 

Stock Compensation expense

 

 

 

 

 

524,047

 

 

 

 

 

 

 

524,047

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

33,198

 

33,198

 

Net Income (restated)

 

 

 

 

 

 

 

2,253,198

 

 

 

 

 

2,253,198

 

Balance at December 31, 2006

 

24,154,749

 

$

24,154

 

$

72,327,719

 

$

6,709,585

 

$

(394,570

)

$

(39,246

)

$

78,627,642

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(restated, see Note 2)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes to consolidated financial statements are an integral part of this statement.

 

5



 

LANNETT COMPANY, INC. AND SUBSIDIARIES

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

(UNAUDITED)

 

 

 

For the six months ended
December 31,

 

 

 

2006

 

2005

 

 

 

(restated, see Note 2)

 

 

 

OPERATING ACTIVITIES:

 

 

 

 

 

Net income

 

$

2,253,198

 

$

2,865,051

 

Adjustments to reconcile net income to net cash provided by (used in) operating activities:

 

 

 

 

 

Depreciation and amortization

 

2,183,971

 

1,930,920

 

Deferred tax expense

 

1,521,665

 

867,483

 

Stock compensation expense

 

524,047

 

685,983

 

Gain from sale of asset

 

(8,208

)

 

Changes in assets and liabilities which provided (used) cash:

 

 

 

 

 

Trade accounts receivable

 

(6,703,247

)

(8,297,320

)

Inventories

 

2,543,477

 

(901,802

)

Prepaid taxes

 

1,016,729

 

1,000,000

 

Prepaid expenses and other assets

 

32,689

 

38,800

 

Accounts payable

 

3,846,194

 

259,862

 

Accrued expenses

 

(955,625

)

1,097,888

 

Net cash provided by (used in) operating activities

 

6,254,890

 

(453,135

)

 

 

 

 

 

 

INVESTING ACTIVITIES:

 

 

 

 

 

Purchases of property, plant and equipment (including construction in progress)

 

(1,069,188

)

(2,678,847

)

Proceeds from sale of asset

 

10,000

 

 

Sales of investment securities - available for sale

 

1,883,289

 

2,249,681

 

Issuance of note receivable

 

(5,346,665

)

(2,000,000

)

Net cash used in investing activities

 

(4,522,564

)

(2,429,166

)

 

 

 

 

 

 

FINANCING ACTIVITIES:

 

 

 

 

 

Repayments of debt

 

(255,426

)

(7,011,182

)

Proceeds from debt, net of restricted cash released

 

 

5,750,000

 

Proceeds from issuance of stock

 

61,271

 

65,051

 

Net cash used in financing activities

 

(194,155

)

(1,196,131

)

 

 

 

 

 

 

NET INCREASE/(DECREASE) IN CASH

 

1,538,171

 

(4,078,432

)

 

 

 

 

 

 

CASH, BEGINNING OF PERIOD

 

468,359

 

4,165,601

 

CASH, END OF PERIOD

 

$

2,006,530

 

$

87,169

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION -

 

 

 

 

 

 

 

 

 

 

 

Interest paid

 

$

75,051

 

$

193,444

 

Income taxes paid

 

$

 

$

 

 

The accompanying notes to consolidated financial statements are an integral part of these statements.

 

6



 

LANNETT COMPANY, INC. AND SUBSIDIARIES

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - UNAUDITED

 

Note 1.  Interim Financial Information

 

The accompanying unaudited financial statements have been prepared in accordance with U.S. generally accepted accounting principles for presentation of interim financial statements and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, the unaudited financial statements do not include all the information and footnotes necessary for a comprehensive presentation of the financial position, results of operations, and cash flows for the periods presented. In the opinion of management, the unaudited financial statements include all the normal recurring adjustments that are necessary for a fair presentation of the financial position, results of operations, and cash flows for the periods presented.  Operating results for the three month and six month periods ended December 31, 2006 are not necessarily indicative of the results that may be expected for the year ending June 30, 2007. You should read these unaudited financial statements in combination with the other Notes in this section; “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing in Item 2; and the Financial Statements, including the Notes to the Financial Statements, included in our Annual Report on Form 10-K for the year ended June 30, 2006.

 

Note 2.  Fiscal 2007 Restatement

 

Lannett Company, Inc. is filing this amendment to its Quarterly Report on Form 10-Q for the period ended December 31, 2006, to amend and restate financial statements and other financial information for the three months and six months ended December 31, 2006.

 

The restatement is the result of an error identified in the fourth quarter of Fiscal 2007, which affected the first, second and third quarters of Fiscal 2007.  We identified a number of production orders that were completed and removed from production in our information system during Fiscal 2007, but for which the month-end process to reduce the work in process (WIP) balance and expense the activity to cost of goods sold (COGS) in the general ledger did not occur. The result was that WIP was overstated and COGS was understated by $840,000 for the full year Fiscal 2007.

 

Another error was identified in the fourth quarter of Fiscal 2007, resulting from the calculation of stock-based compensation expense.  It also affected the first, second and third quarters of Fiscal 2007.   We identified in the fourth quarter of Fiscal 2007 that the estimated life of stock options was incorrectly calculated.  The result was that stock compensation expense was misstated in each quarter of Fiscal 2007.  The affect for the second quarter Fiscal 2007 was an understatement of $19,707.  The three quarters amounted to an overstatement of $52,000 combined

 

After determining the error did not affect any prior Fiscal years, management recommended to the Audit Committee of the Board of Directors that previously reported financial results from Fiscal 2007 be restated to include the effects of these errors.  The Audit Committee discussed and agreed with this recommendation.  The restatement resulted from a material weakness identified with respect to the failure to correctly process inventory and cost of goods sold amounts in the company’s information system in addition to failure to detect such processing error through account reconciliations.

 

This current Form 10-Q/A includes the effect of the adjustment from the three months and six months ended December 31, 2006. The following table summarizes the effects of the change on relevant accounts within the Consolidated Balance Sheets and Consolidated Statements of Income:

 

7



 

This current Form 10-Q/A also includes the effect of the year-to-date adjustment, the impact of which is summarized as follows:

 

 

 

December 31, 2006

 

 

 

As previously reported

 

As restated

 

Consolidated Balance Sheets

 

 

 

 

 

Inventories

 

$

 9,485,026

 

$

 8,933,026

 

Additional paid in capital

 

$

 72,318,937

 

$

 72,327,720

 

Deferred Tax Asset

 

$

 16,324,696

 

$

 16,549,009

 

 

 

 

Three months ended

 

 

 

December 31, 2006

 

 

 

As previously reported

 

As restated

 

Consolidated Statements of Operations

 

 

 

 

 

Cost of sales (excluding amortization of intangible asset)

 

$

 17,244,285

 

$

 17,402,285

 

Selling, general and administrative expense

 

1,961,956

 

1,981,664

 

 

 

 

 

 

 

Operating income

 

1,725,832

 

1,548,124

 

Income Tax Expense

 

707,864

 

636,781

 

Net income

 

$

 1,061,796

 

$

 955,171

 

 

 

 

 

 

 

per share amounts

 

 

 

 

 

Basic earnings per common share

 

$

 0.04

 

$

 0.04

 

Diluted earnings per common share

 

$

 0.04

 

$

 0.04

 

 

 

 

 

 

 

Basic shares outstanding

 

24,154,553

 

24,154,553

 

Diluted shares outstanding

 

24,222,515

 

24,222,515

 

 

This current Form 10-Q/A also includes the effect of the year-to-date adjustments, the impact of which is summarized as follows:

 

 

 

Six months ended

 

 

 

December 31, 2006

 

 

 

As previously reported

 

As restated

 

Consolidated Statements of Operations

 

 

 

 

 

Cost of sales (excluding amortization of intangible asset)

 

$

 30,090,680

 

$

 30,642,680

 

Selling, general and administrative expense

 

6,344,458

 

6,353,241

 

 

 

 

 

 

 

Operating income

 

4,240,166

 

3,679,383

 

Income Tax Expense

 

1,728,911

 

1,504,598

 

Net income

 

$

 2,589,666

 

$

 2,253,198

 

 

 

 

 

 

 

per share amounts

 

 

 

 

 

Basic earnings per common share

 

$

 0.11

 

$

 0.09

 

Diluted earnings per common share

 

$

 0.11

 

$

 0.09

 

 

 

 

 

 

 

Basic shares outstanding

 

24,151,237

 

24,151,237

 

Diluted shares outstanding

 

24,197,946

 

24,197,946

 

 

8



 

Note 3.  Summary of Significant Accounting Policies

 

Lannett Company, Inc., a Delaware Corporation, and subsidiaries (the “Company”), develop, manufacture, package, market, and distribute pharmaceutical products sold under generic chemical names.  The Company primarily manufactures solid oral dosage forms, including tablets and capsules, and is pursuing partnerships and research contracts for the development and production of other dosage forms, including liquids and injectable products.

 

Revenue recognition and accounts receivable, adjustments for chargebacks, rebates and returns, allowance for doubtful accounts and realization of deferred income tax assets represent significant estimates made by management.

 

Principles of Consolidation - The consolidated financial statements include the accounts of the operating parent company, Lannett Company, Inc., and its wholly owned subsidiaries, Lannett Holdings, Inc. and an inactive subsidiary.

 

Revenue Recognition - The Company maintains pricing agreements with all customers.  Revenue is recognized at the agreed price upon delivery to the customer, when title and risk of loss have transferred to the customer, collectibility is reasonably assured and provisions for estimates, including rebates, promotional adjustments, price adjustments, returns, chargebacks, and other potential adjustments are reasonably determinable.  Accruals for these provisions are presented in the consolidated financial statements as rebates and chargebacks payable on the balance sheet and are included in net sales, as reductions, on the statement of income.  Net sales, as presented in the statements of income, are based upon revenue earned upon shipment, less reserves for chargebacks, rebates, returns and other adjustments to sales.

 

Chargebacks – The chargeback provision is based upon contracted prices with customers, and the accuracy of this provision is affected by changes in product sales mix and by the length of time it takes for wholesalers to move the products to the ultimate customers. This is considered the most significant and complex estimate used in the recognition of revenue.

 

The chargeback process begins when the Company sells its products through wholesalers to “indirect customers” such as independent pharmacies, managed care organizations, hospitals, nursing homes, and group purchasing organizations.  The Company enters into agreements with its indirect customers to establish pricing for certain products.  The indirect customers then select a wholesaler from which to receive the products at these contractual prices.

 

Upon the sale of a product to a wholesaler, the Company records the estimated chargeback provision based upon estimated indirect customers’ purchases and the contract prices with those indirect customers.  Once the sale to the indirect customer occurs, the wholesaler requests a chargeback credit from the Company equal to the difference between the contractual price with the indirect customer and the wholesaler’s invoice price, if the price sold to the indirect customer is lower than the direct price to the wholesaler.  The provision for chargebacks is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers.

 

Rebates – Rebates are offered to the Company’s key customers and buying groups to promote customer loyalty and encourage product sales.  These rebate programs provide customers with rebate credits upon attainment of pre-established volumes or attainment of net sales milestones for a specified period.  Other promotional programs are incentive programs offered to the customers.  At the time of shipment, the Company estimates reserves for rebates and other promotional credit programs based on the specific terms in each agreement.  The reserve for rebates increases as sales to certain wholesale and retail customers increase.  However, these rebate programs are tailored to the customers’ individual programs.  Hence, the reserve will depend on the mix of customers that comprise such rebate programs.

 

Returns – Consistent with industry practice, the Company has a product returns policy that allows certain customers to return product within a specified period before and after the product’s lot expiration date in exchange for a credit to be applied against future purchases.  The Company’s policy requires that the customer

 

9



 

obtain pre-approval from the Company for any qualifying return.  The Company estimates its provision for returns based on historical experience, business practices, and credit terms.  While such experience has allowed for reasonable estimations in the past, historical returns may not always be an accurate indicator of future returns.  The Company monitors the provisions for returns and makes adjustments when management believes that actual product returns may differ from established reserves.  Generally, the reserve for returns increases as net sales increase.  The reserve for returns is included in rebates and chargebacks payable on the balance sheet.

 

Other Adjustments – Other adjustments consist primarily of price adjustments, also known as “shelf stock adjustments,” which are credits issued to reflect decreases in the selling prices of the Company’s products that customers have remaining in their inventories at the time of the price reduction.  Decreases in selling prices are discretionary decisions made by management in response to competitive market conditions.  Amounts recorded for estimated shelf stock adjustments are based upon specified terms with direct customers, expected declines in market prices, and estimates of inventory held by customers.  The Company regularly monitors these and other factors and evaluates the reserve as additional information becomes available.  Other adjustments are included in rebates and chargebacks payable on the balance sheet.

 

The following tables identify the reserves for each major category of revenue allowance and a summary of the activity for the six months ended December 31, 2006 and 2005:

 

For the six months ended December 31, 2006

 

Reserve Category

 

Chargebacks

 

Rebates

 

Returns

 

Other

 

Total

 

Reserve balance as of June 30, 2006

 

$

10,137,400

 

$

 2,183,100

 

$

 416,000

 

$

 275,600

 

$

 13,012,100

 

Actual credits issued related to sales recorded in prior fiscal years

 

(10,120,000

)

(1,702,800

)

(869,500

)

(219,000

)

(12,911,300

)

Reserves or (reversals) charged during Fiscal 2007 related to sales recorded in prior fiscal years

 

 

(300,000

)

460,000

 

 

160,000

 

Reserves charged to net sales during fiscal 2007 related to sales recorded in fiscal 2007

 

15,851,400

 

5,750,100

 

590,000

 

350,000

 

22,541,500

 

Actual credits issued related to sales recorded in Fiscal 2007

 

(10,065,500

)

(3,808,500

)

(254,700

)

(115,000

)

(14,243,700

)

Reserve balance as of December 31, 2006

 

$

 5,803,300

 

$

 2,121,900

 

$

 341,800

 

$

 291,600

 

$

 8,558,600

 

 

For the six months ended December 31, 2005

 

Reserve Category

 

Chargebacks

 

Rebates

 

Returns

 

Other

 

Total

 

Reserve Balance as of June 30, 2005

 

$

 7,999,700

 

$

 1,028,800

 

$

1,692,000

 

$

 29,500

 

$

 10,750,000

 

Actual credits issued related to sales recorded in prior fiscal years

 

(7,100,000

)

(950,000

)

(1,450,000

)

(29,500

)

(9,529,500

)

Reserves or (reversals) charged during Fiscal 2006 related to sales recorded in prior fiscal years

 

 

 

 

 

 

Reserves charged to net sales during fiscal 2006 related to sales recorded in fiscal 2006

 

10,756,100

 

2,697,600

 

602,900

 

470,300

 

14,526,900

 

Actual credits issued related to sales recorded in Fiscal 2006

 

(3,674,300

)

(2,487,100

)

(129,400

)

(382,300

)

(6,673,100

)

Reserve Balance as of December 31, 2005

 

$

 7,981,500

 

$

 289,300

 

$

 715,500

 

$

 88,000

 

$

 9,074,300

 

 

Please see the discussion regarding the above tables in Management’s Discussion and Analysis.

 

10



 

Accounts Receivable - The Company continuously monitors collections and payments from its customers and maintains a provision for estimated credit losses based upon historical experience and any specific customer collection issues that have been identified. This provision is $250,000 at December 31, 2006 and June 30, 2006.

 

Fair Value of Financial Instruments - The Company’s financial instruments consist primarily of cash and cash equivalents, trade receivables, trade payables and debt instruments. The carrying values of cash and cash equivalents, trade receivables, and trade payables are considered to be representative of their respective fair values.  The Company’s debt instruments are fixed rate, with a lower interest rate than the prevailing market rates. The Company has been able to obtain favorable rates through Philadelphia and Pennsylvania Industrial Development Authorities.

 

Deferred Debt Acquisition Costs - Costs incurred in connection with obtaining financing are amortized by the straight-line method over the term of the loan arrangements.  These costs are included in interest expense in the Consolidated Statements of Income.  Amortization expense for debt acquisition costs for the three months ended December 31, 2006 and 2005 was approximately $9,000 and $ 36,000, respectively, and for the six months ended December 31, 2006 and 2005 was approximately $18,000 and $ 42,000, respectively

 

Shipping and Handling Costs – The cost of shipping products to customers is recognized at the time the products are shipped, and is included in Cost of Sales.

 

Research and Development – Research and development expenses are charged to operations as incurred.

 

Advertising Costs - The Company charges advertising costs to operations as incurred.

 

Segment Information The Company reports segment information in accordance with Statement of Financial Accounting Standard No. 131 (FAS 131), Disclosures about Segments of an Enterprise and Related Information.  The Company operates one business segment – generic pharmaceuticals – and one reporting segment.  In accordance with FAS 131, the Company aggregates its financial information for all products and reports on one operating segment.  The Company’s products contain various active pharmaceutical ingredients aimed at treating a diverse range of medical indications.  The following table identifies the Company’s approximate net product sales by medical indication for the three and six months ended December 31, 2006 and 2005:

 

 

 

For the Three Months Ended
December 31,

 

For the Six Months Ended
December 31,

 

Medical Indication

 

2006

 

2005

 

2006

 

2005

 

 

 

 

 

 

 

 

 

 

 

Migraine Headache

 

$

 2,671,000

 

$

 3,346,000

 

$

 5,162,000

 

$

 6,519,000

 

Epilepsy

 

1,815,000

 

3,329,000

 

4,473,000

 

6,689,000

 

Heart Failure

 

1,000,000

 

1,518,000

 

2,503,000

 

3,266,000

 

Thyroid Deficiency

 

12,118,000

 

3,411,000

 

18,278,000

 

7,280,000

 

Antibacterial

 

4,428,000

 

1,598,000

 

12,090,000

 

2,036,000

 

Other

 

884,000

 

2,027,000

 

2,378,000

 

3,080,000

 

 

 

 

 

 

 

 

 

 

 

Total

 

$

 22,916,000

 

$

 15,229,000

 

$

 44,884,000

 

$

 28,870,000

 

 

11



 

Stock Options - In December 2004, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards (SFAS) No. 123 (R), “Share-Based Payment” (SFAS 123(R)).  This standard is a revision of SFAS 123, “Accounting for Stock-Based Compensation” and supersedes Accounting Principles Board Opinion (“APB”) No. 25, “Accounting for Stock Issued to Employees.”   SFAS 123(R) addresses the accounting for share-based compensation in which we receive employee services in exchange for our equity instruments.  Under the standard, we are required to recognize compensation cost for share-based compensation issued to or purchased by employees, net of estimated forfeitures, under share-based compensation plans using a fair value method.

 

At December 31, 2006, the Company had two stock-based employee compensation plans.  Prior to July 1, 2005, the Company accounted for those plans under the recognition and measurement provisions of APB 25, and related Interpretations, as permitted by SFAS 123.  Effective July 1, 2005, the Company adopted the fair value recognition provisions of SFAS 123(R), using the modified-prospective-transition method.

 

Accordingly, prior periods have not been restated.  Under this method, the Company is required to record compensation expense for all awards granted after the date of adoption and for the unvested portion of previously granted awards that remained outstanding as of the beginning of the period of adoption.  The Company measures share-based compensation cost using the Black-Scholes option pricing model.  The following table presents the weighted average assumptions used to estimate fair values of the stock options granted during the six months ended December 31, 2006:

 

Risk-free interest rate

 

4.74

%

Expected volatility

 

59

%

Expected dividend yield

 

0.0

%

Expected term (in years)

 

5.00

 

 

There were approximately 220,000 and 354,000 options issued during the three and six months ended December 31, 2006. This compares to approximately 20,000 options issued during the three and six months ended December 31, 2005.  375 shares under option were exercised in the three and six months ended December 31, 2006, resulting in proceeds of $281 to the Company.  There were no exercises in the three and six month periods ended December 31, 2005.

 

Expected volatility is based on the historical volatility of the price of our common shares since active trading commenced on the American Stock Exchange in April 2002.  We use historical information to estimate expected term within the valuation model.  The expected term of awards represents the period of time that options granted are expected to be outstanding.  The risk-free rate for periods within the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of grant.  Compensation cost is recognized using a straight-line method over the vesting or service period and is net of estimated forfeitures.

 

The forfeiture rate assumption is the estimated annual rate at which unvested awards are expected to be forfeited during the vesting period. This assumption is based on our historical forfeiture rate.  Periodically, management will assess whether it is necessary to adjust the estimated rate to reflect changes in actual forfeitures or changes in expectations.  For example, adjustments may be needed if, historically, forfeitures were affected mainly by turnover that resulted from a business restructuring that is not expected to recur.  The increase in the forfeiture rate from 3% at December 31, 2005 to 5.0% at December 31, 2006 is an adjustment made to account for recent turnover at manager levels.  As the Company continues to grow, this rate is likely to change to match such changes in growth businesses.  Under the provisions of FAS 123R, the Company will incur additional expense if the actual forfeiture rate is lower than originally estimated.  A recovery of prior expense will be recorded if the actual rate is higher than originally estimated.

 

12



 

The following table presents all share-based compensation costs recognized in our statements of income as part of selling, general and administrative expenses: 

 

 

 

Three Months Ended
December 31,

 

Six Months Ended
December 31,

 

 

 

2006

 

2005

 

2006

 

2005

 

 

 

(restated,
see Note 2)

 

 

 

(restated, see
Note 2)

 

 

 

Method used to account for share-based compensation

 

Fair Value

 

Fair Value

 

Fair Value

 

Fair Value

 

Share-based compensation under SFAS 123(R)

 

$

 277,698

 

$

 359,301

 

$

 524,047

 

$

 685,983

 

Tax benefit

 

$

 46,940

 

$

 79,350

 

$

 93,881

 

$

 158,700

 

 

Options outstanding that have vested and are expected to vest as of December 31, 2006 are as follows:

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

Weighted-

 

 

 

Average

 

 

 

 

 

Average

 

Aggregate

 

Remaining

 

 

 

 

 

Exercise

 

Intrinsic

 

Contractual

 

 

 

Awards

 

Price

 

Value

 

Life

 

Vested

 

564,375

 

$

 11.54

 

$

 85,274

 

6.7

 

Expected to vest

 

546,550

 

$

 7.26

 

$

 263,223

 

9.2

 

Total

 

1,110,925

 

$

 9.38

 

$

 348,497

 

7.9

 

 

A summary of award activity under the Plans as of December 31, 2006 and 2005, and changes during the six months then ended, is presented below:

 

 

 

 

 

Weighted-

 

 

 

Weighted

 

 

 

 

 

Average

 

Aggregate

 

Average

 

 

 

 

 

Exercise

 

Intrinsic

 

Remaining

 

 

 

Awards

 

Price

 

Value

 

Contractual Life

 

Outstanding at July 1, 2006

 

792,003

 

$

 10.89

 

 

 

7.3

 

Granted

 

353,783

 

$

 6.02

 

 

 

 

 

Exercised

 

375

 

0.75

 

$

 2,063

 

 

 

Forfeited or expired

 

5,720

 

10.73

 

 

 

 

 

Outstanding at December 31, 2006

 

1,139,691

 

$

 9.38

 

$

 362,351

 

7.9

 

Outstanding at December 31, 2006 and not yet vested

 

575,316

 

$

 7.26

 

$

 277,076

 

9.2

 

Exercisable at December 31, 2006

 

564,375

 

$

 11.54

 

$

 85,274

 

6.7

 

 

 

 

 

 

Weighted-

 

 

 

Weighted

 

 

 

 

 

Average

 

Aggregate

 

Average

 

 

 

 

 

Exercise

 

Intrinsic

 

Remaining

 

 

 

Awards

 

Price

 

Value

 

Contractual Life

 

Outstanding at July 1, 2005

 

857,108

 

$

 13.72

 

 

 

 

 

Granted

 

83,500

 

$

 5.18

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

Forfeited or expired

 

 

 

 

 

 

 

Outstanding at December 31, 2005

 

940,608

 

$

 11.33

 

$

 340,320

 

8.2

 

Outstanding at December 31, 2005 and not yet vested

 

418,527

 

$

 11.17

 

$

 245,110

 

8.4

 

Exercisable at December 31, 2005

 

522,081

 

$

 11.45

 

$

 95,210

 

7.8

 

 

As of December 31, 2006, there was approximately $1,744,000 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 1.6 years.  As of December 31, 2005, there was approximately $1,806,000 of

 

13



 

total unrecognized compensation cost related to nonvested share-based compensation awards granted under the Plans.

 

Unearned Grant Funds – The Company records all grant funds received as a liability until the Company fulfills all the requirements of the grant funding program.

 

Note 4.  New Accounting Standards

 

In May 2005, the FASB issued SFAS No. 154, “Accounting Changes and Error Corrections – a replacement of APB Opinion No. 20 and FASB Statement No. 3” (SFAS No. 154), which replaces APB Opinion No. 20, “Accounting Changes,” and SFAS No. 3, “Reporting Accounting Changes in Interim Financial Statements,” and changes the requirements for the accounting for and reporting of a change in accounting principle. SFAS No. 154 requires companies to recognize a change in accounting principle retrospectively in prior period financial statements.  This applies to all voluntary changes in accounting principle, and also applies to changes required by an accounting pronouncement in the unusual instance that the pronouncement does not include specific transition provisions. SFAS No. 154 is effective for accounting changes and corrections of errors made in fiscal years beginning after December 15, 2005, which, in the Company’s case, is the current fiscal year beginning July 1, 2006. SFAS No. 154 does not change the transition provisions of any existing accounting pronouncements, including those that are in a transition phase as of the effective date of SFAS No. 154.  The adoption of this standard did not have a material impact on our financial statements.

 

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements” (SFAS 157).  This Statement defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles (GAAP), and expands disclosures about fair value measurements. This Statement applies under other accounting pronouncements that require or permit fair value measurements, the Board having previously concluded in those accounting pronouncements that fair value is the relevant measurement attribute. Accordingly, this Statement does not require any new fair value measurements. However, for some entities, the application of this Statement will change current practice.  This Statement is effective for financial statements issued for fiscal years beginning after November 15, 2007, and interim periods within those fiscal years.  The Company will be required to adopt the guidance of SFAS 107 beginning July 1, 2008.  The Company has not completed its study of the effects of adopting this standard.

 

In July 2006, the FASB issued Interpretation No. 48, “Accounting for Uncertainty in Income Taxes” (FIN 48), to clarify the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with SFAS 109, “Accounting for Income Taxes.” Effective for fiscal years beginning after December 15, 2006, FIN 48 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company will be required to adopt the guidance of FIN 48 beginning July 1, 2007.  While earlier adoption is permitted by the FASB, the Company has not yet completed its evaluation of the impact that adoption of FIN 48 will have on its financial statements.

 

In September 2006, the SEC staff issued Staff Accounting Bulletin No. 108, “Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements.”  SAB 108 was issued to provide consistency between how registrants quantify financial statement misstatements.

 

Historically, there have been two widely-used methods for quantifying the effects of financial statement misstatements.  These methods are referred to as the “roll-over” and “iron curtain” method.  The roll-over method quantifies the amount by which the current year income statement is misstated.  Exclusive reliance on an income statement approach can result in the accumulation of errors on the balance sheet that may not have been material to any individual income statement, but which may misstate one or more balance sheet accounts.  The iron curtain method quantifies the error as the cumulative amount by which the current year balance sheet is misstated.   Exclusive reliance on a balance sheet approach can result in disregarding the effects of errors in the

 

14



 

current year income statement that results from the correction of an error existing in previously issued financial statements.  We currently use the roll-over method for quantifying identified financial statement misstatements.

 

SAB 108 established an approach that requires quantification of financial statement misstatements based on the effects of the misstatement on each of the Company’s financial statements and the related financial statement disclosures.  This approach is commonly referred to as the “dual approach” because it requires quantification of errors under both the roll-over and iron curtain methods.

 

SAB 108 allows registrants to initially apply the dual approach either by (1) retroactively adjusting prior financial statements as if the dual approach had always been used or by (2) recording the cumulative effect of initially applying the dual approach as adjustments to the carrying values of assets and liabilities as of July 1, 2006 with an offsetting adjustment recorded to the opening balance of retained earnings.    Use of this “cumulative effect” transition method requires detailed disclosure of the nature and amount of each individual error being corrected through the cumulative adjustment and how and when it arose.

 

The effective date for SAB 108 is the first fiscal year ending after November 15, 2006.  For Lannett, SAB 108 is effective immediately, for the fiscal year ending June 30, 2007.  The Company has not yet determined the effect of adopting this guidance, but will be completing an analysis on the effect of this guidance before the end of the fiscal year.

 

Note 5.  Inventories

 

The Company values its inventories at the lower of cost (determined by the first-in, first-out method) or market, regularly reviews inventory quantities on hand, and records a provision for excess and obsolete inventory based primarily on estimated forecasts of product demand and production requirements.  Inventories consist of:

 

 

 

December 31, 2006

 

June 30, 2006

 

 

 

(restated,see Note 2)

 

 

 

Raw material

 

$

3,938,383

 

$

5,143,714

 

Work-in-process

 

965,984

 

1,438,794

 

Finished goods

 

3,631,856

 

4,511,274

 

Packaging supplies

 

396,803

 

382,721

 

 

 

$

8,933,026

 

$

11,476,503

 

 

The preceding amounts are net of inventory reserves of $1,306,830 and $1,054,498 at December 31, 2006 and June 30, 2006, respectively.

 

Note 6.  Property, Plant and Equipment

 

Property, plant and equipment are stated at cost.  Depreciation is provided for by the straight-line and accelerated methods over estimated useful lives of the assets.  Depreciation expense for the three months ended December 31, 2006 and 2005 was approximately $658,000 and $530,000, respectively.  Depreciation expense for the six months ended December 31, 2006 and 2005 was approximately $1,292,000 and $1,039,000, respectively.   Property, plant and equipment consist of the following:

 

 

 

 

 

December 31,

 

June 30,

 

 

 

Useful Lives

 

2006

 

2006

 

Land

 

 

$

233,414

 

$

233,414

 

Building and improvements

 

10 - 39 years

 

11,974,573

 

10,612,954

 

Machinery and equipment

 

5 - 10 years

 

17,981,152

 

17,109,279

 

Furniture and fixtures

 

5 - 7 years

 

826,703

 

826,703

 

 

 

 

 

$

31, 015,842

 

$

28,782,350

 

 

15



 

Note 7.  Investment Securities - Available-for-Sale

 

The Company’s investment securities consist of marketable debt securities, primarily in U.S. government and agency obligations, and a $500,000 equity investment in an Active Pharmaceutical Ingredient (“API”) provider.  All of the Company’s marketable debt securities are classified as available-for-sale and recorded at fair value, based on quoted market prices.  The Company accounts for its investment in the API provider at cost.  Unrealized holding gains and losses are recorded, net of any tax effect, as a separate component of accumulated other comprehensive income.  No gains or losses on marketable debt securities are realized until they are sold or a decline in fair value is determined to be other-than-temporary.  If a decline in fair value is determined to be other-than-temporary, an impairment charge is recorded and a new cost basis in the investment is established. There were no securities determined by management to be other-than-temporarily impaired for the six month period ended December 31, 2006.

 

The amortized cost, gross unrealized gains and losses, and fair value of the Company’s available-for-sale securities are summarized as follows:

 

 

 

 

December 31, 2006

 

 

 

 

Available-for-Sale

 

 

 

 

Amortized
Cost

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Fair
Value

 

U.S. Government Agency

 

$

2,093,726

 

$

5,976

 

$

(27,234

)

$

2,072,469

 

Asset-Backed Securities

 

 

1,243,202

 

 

6,078

 

 

(50,231

)

 

1,199,050

 

Other Investments

 

 

500,000

 

 

 

 

 

 

500,000

 

 

 

$

3,836,928

 

$

12,055

 

$

(77,465

)

$

3,771,518

 

 

 

 

June 30, 2006

 

 

 

Available-for-Sale

 

 

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Fair
Value

 

U.S. Government Agency

 

$

3,593,368

 

$

15

 

$

(67,510

)

3,525,873

 

Asset-Backed Securities

 

1,648,981

 

63

 

(53,308

)

1,595,736

 

Other Investments

 

500,000

 

 

 

500,000

 

 

 

$

5,742,349

 

$

78

 

$

(120,818

)

$

5,621,609

 

 

 

The amortized cost and fair value of the Company’s current available-for-sale securities by contractual maturity at December 31, 2006 are summarized as follows:

 

 

 

December 31, 2006

 

 

 

Available for Sale

 

 

 

Amortized

 

Fair

 

 

 

Cost

 

Value

 

Due in one year or less

 

$

201,540

 

$

197,750

 

Due after one year through five years

 

2,610,671

 

2,596,617

 

Due after five years through ten years

 

134,819

 

130,626

 

Due after ten years

 

889,898

 

846,525

 

 

 

$

3,836,928

 

$

3,771,518

 

 

The Company uses the specific identification method to determine the cost of securities sold. There were no securities held from a single issuer that represented more than 15% of shareholders’ equity.

 

16



 

The table below indicates the length of time individual securities have been in a continuous unrealized loss position as of December 31, 2006:

 

 

 

December 31, 2006

 

 

 

 

 

Less than 12 months

 

12 months or longer

 

Total

 

Description of

 

Number of

 

Fair

 

Unrealized

 

Fair

 

Unrealized

 

Fair

 

Unrealized

 

Securities

 

Securities

 

Value

 

Loss

 

Value

 

Loss

 

Value

 

Loss

 

U.S. Government Agency

 

6

 

499,227

 

(505

)

717,740

 

(26,729

)

1,216,968

 

(27,234

)

Asset-Backed Securities

 

12

 

 

 

1,074,367

 

(50,231

)

1,074,367

 

(50,231

)

Total tempory impaired investment securities

 

18

 

$

499,227

 

$

(505

)

$

1,792,107

 

$

(76,960

)

$

2,291,335

 

$

(77,465

)

 

The investment securities shown above currently have fair values less than amortized cost and therefore contain unrealized losses. The Company has evaluated these securities and has determined that the decline in value is not related to any company or industry specific event. At December 31, 2006, there were approximately 18 out of 24 investment securities with unrealized losses. The Company anticipates full recovery of amortized costs with respect to these securities at maturity or sooner in the event of a more favorable market interest rate environment.  Realized gains and losses from sale of investment securities have been immaterial for the three and six month periods ended December 31, 2006 and 2005.

 

Note 8. Note Receivable

 

A loan agreement with an API provider (the “Borrower”) was entered in July 2005.  In the agreement, the Company loaned the Borrower $2,000,000 to finance general business activities.  Additional loans have been made to the Borrower since the loan was initiated.  The current balance owed by the Borrower is approximately $8.5 million.  The note receivable is backed by a promissory note and a security interest in substantially all the Borrower’s assets.  Interest on the principal balance will be earned at 10% per annum for the first three years, and then at variable rates based on the Prime Rate plus 500 basis points.  The agreement calls for the Borrower to pay all interest that has accrued and is due and owing on the Loan on the first, second and third anniversary date of this Agreement.  The borrower requested an extension to the first interest payment, which was due in July 2006.  The borrower subsequently made this interest payment in January 2007.  The Borrower shall pay the principal balance on the loan, plus accrued interest, in twenty four equal consecutive monthly installments beginning July 2008.  Management currently believes this loan is fully collectible,  In the event of a default on the loan, the Company would be able to liquidate the net assets of the Borrower.  However, there is no guarantee that the net assets of the Borrower will be sufficient to allow the full repayment of the existing loan.  In the event that some or the entire loan is deemed uncollectible, a reserve will be established to recognize the amount considered uncollectible.

 

Note 9. Bank Line of Credit

 

The Company has a $3,000,000 line of credit from Wachovia Bank, N.A. that bears interest at the prime interest rate less 0.25% (8.0% at December 31, 2006). The line of credit was renewed and extended to November 30, 2007.  At December 31, 2006 and 2005, the Company had $0 outstanding under the line of credit.  The line of credit is collateralized by substantially all of the Company’s assets. The Company currently has no plans to borrow under this line of credit.

 

17



 

Note 10.  Unearned Grant Funds

 

In July 2004, the Company received $500,000 of grant funding from the Commonwealth of Pennsylvania, acting through the Department of Community and Economic Development.  The grant funding program requires the Company to use the funds for machinery and equipment located at their Pennsylvania locations, hire an additional 100 full-time employees by June 30, 2006, operate its Pennsylvania locations a minimum of five years and meet certain matching investment requirements.  If the Company fails to comply with any of the requirements above, the Company would be liable to repay the full amount of the grant funding ($500,000).  The Company records the unearned grant funds as a liability until the Company complies with all of the requirements of the grant funding program.  On a quarterly basis, the Company will monitor its progress in fulfilling the requirements of the grant funding program and will determine the status of the liability.  As of December 31, 2006, the grant funding is recognized as a short term liability under the caption of Unearned Grant Funds, since the Company has not yet met the requirement to add 100 full-time employees.   However, the Company is requesting an extension of this obligation to add 100 employees, since the other requirement related to use of funds has been met already, and the requirement to operate its Pennsylvania locations is still ongoing.

 

Note 11.  Long-Term Debt

 

Long-term debt consists of the following:

 

 

 

December 31,

 

June 30,

 

 

 

2006

 

2006

 

PIDC Regional Development Center, LP III loan

 

$

4,500,000

 

$

4,500,000

 

Pennsylvania Industrial Development Authority loan

 

1,205,000

 

1,222,000

 

Pennsylvania Department of Community & Economic Development loan

 

453,000

 

476,000

 

Tax-exempt bond loan (PAID)

 

901,000

 

956,000

 

Equipment loan

 

882,000

 

1,043,000

 

Total debt

 

7,941,000

 

8,197,000

 

Less current portion

 

592,000

 

547,000

 

Long term debt

 

$

7,349,000

 

$

7,650,000

 

 

On December 13, 2005, the Company refinanced $5,750,000 of its debt through the Philadelphia Industrial Development Corporation (PIDC) and the Pennsylvania Industrial Development Authority (PIDA).  With the proceeds from the refinancing, the Company paid off its Mortgage and Construction Loan, as well as a portion of the Equipment loan.  These loans were with Wachovia Bank.  The Company financed $4,500,000 through the Immigrant Investor Program (PIDC Regional Center, LP III).  The Company will pay a bi-annual interest payment at a rate equal to two and one-half percent per annum.  The outstanding principal balance shall be due and payable 5 years (60 months) from January 1, 2006.  The remaining $1,250,000 is financed through the PIDA Loan.  The Company is required to make equal payments each month for 180 months starting February 1, 2006 with interest of two and three-quarter percent per annum.  The PIDA Loan has $1,204,706 outstanding as of December 31, 2006, and $87,127 is currently due; none of the PIDC Loan is currently due.

 

An additional $500,000 was financed through the Pennsylvania Department of Community and Economic Development Machinery and Equipment Loan Fund.  The Company is required to make equal payments for 60 months starting May 1, 2006 with interest of 2.75% per annum.  As of December 31, 2006, $453,051 is outstanding, and $119,961 is currently due.

 

18



 

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 Company’s proceeds from the bonds was used to pay for bond issuance costs of approximately $170,000.  The Trust Indenture requires that the Company repay the Authority loan through installment payments beginning in May 2003 and continuing through May 2014, the year the bonds mature. The bonds bear interest at the floating variable rate determined by the organization responsible for selling the bonds (the “remarketing agent”).  The interest rate fluctuates on a weekly basis.  The effective interest rate at December 31, 2006 was 4.1%.  At December 31, 2006, the Company has $900,983 outstanding on the Authority loan, of which $64,167 is classified as currently due.  The remainder is classified as a long-term liability. In April 1999, an irrevocable letter of credit of $3,770,000 was issued by Wachovia Bank, National Association (Wachovia) to secure payment of the Authority Loan and a portion of the related accrued interest.  At December 31, 2006, no portion of the letter of credit has been utilized.

 

The Equipment Loan consists of a term loan with a maturity of five years.  The Company, as part of the 2003 Loan Financing agreement with Wachovia, is required to make equal payments of principal and interest.  As of December 31, 2006, the Company has outstanding $882,526 under the Equipment Loan, of which $320,520 is classified as currently due.

 

The financing facilities under the 2003 Loan Financing, of which only the Equipment Loan is left, bear interest at a variable rate equal to the LIBOR rate plus 150 basis points.  The LIBOR rate is the rate per annum, based on a 30-day interest period, quoted two business days prior to the first day of such interest period for the offering by leading banks in the London interbank market of dollar deposits.  As of December 31, 2006, the interest rate for the 2003 Loan Financing (of which only the Equipment loan remains) was 6.85%.

 

The Company has executed Security Agreements with Wachovia, PIDA and PIDC in which the Company has agreed to pledge substantially all of its assets to collateralize the amounts due.

 

The terms of the Equipment loan require that the Company meet certain financial covenants and reporting standards, including the attainment of standard financial liquidity and net worth ratios.  As of December 31, 2006, the Company has complied with such terms, and successfully met its financial covenants.

 

Long-term debt amounts due, for the twelve month periods ended December 31 are as follows:

 

12 month period ended

 

Amounts Payable

 

December 31,

 

to Institutions

 

 

 

 

 

2007

 

592,000

 

2008

 

604,000

 

2009

 

538,000

 

2010

 

4,808,000

 

2011

 

343,000

 

Thereafter

 

1,056,000

 

 

 

$

7,941,000

 

 

19



 

Note 12.  Income Taxes

 

The Company uses the liability method specified by Statement of Financial Accounting Standards No. 109 (FAS 109), Accounting for Income Taxes.  Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities as measured by the enacted tax rates which will be in effect when these differences reverse.  Deferred tax expense is the result of changes in deferred tax assets and liabilities.

 

The provision for federal, state and local income taxes for the three month period ended December 31, 2006 and 2005 was $637,000 (restated, see Note 2) and $843,000, respectively, with effective tax rates of 40% and 40%, respectively.  The provision for federal, state and local income taxes for the six month period ended December 31, 2006 and 2005 was $1,505,000 (restated, see Note 2) and $1,896,000, respectively, with effective tax rates of 40% and 40%, respectively.

 

Note 13.  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 Company’s consolidated statement of income and a reconciliation of the computation of basic earnings per share to diluted earnings per share.  Basic earnings per share excludes the dilutive impact of common stock equivalents and is computed by dividing net income by the weighted-average number of shares of common stock outstanding for the period.  Diluted earnings per share includes the effect of potential dilution from the exercise of outstanding common stock equivalents into common stock using the treasury stock method.  Earnings per share amounts for all periods presented have been calculated in accordance with the requirements of FAS 128.  A reconciliation of the Company’s basic and diluted earnings per share follows:

 

 

 

Three Months Ended December 31,

 

 

 

2006

 

2005

 

 

 

Net Income

 

Shares

 

Net Income

 

Shares

 

 

 

(Numerator)

 

(Denominator)

 

(Numerator)

 

(Denominator)

 

 

 

(restated, see Note 2)

 

 

 

 

 

 

 

Basic earnings per share factors

 

$

955,171

 

24,154,533

 

$

1,264,850

 

24,125,884

 

 

 

 

 

 

 

 

 

 

 

Effect of dilutive stock options

 

 

67,982

 

 

25,338

 

 

 

 

 

 

 

 

 

 

 

Diluted earnings per share factors

 

$

955,171

 

24,222,515

 

$

1,264,850

 

24,151,222

 

 

 

 

 

 

 

 

 

 

 

Basic earnings per share

 

$

0.04

 

 

 

$

0.05

 

 

 

Diluted earnings per share

 

$

0.04

 

 

 

$

0.05

 

 

 

 

The number of anti-dilutive weighted average shares that have been excluded in the computation of diluted earnings per share for the three months ended December 31, 2006 and 2005 were 869,804 and 871,428, respectively.

 

20



 

 

 

Six Months Ended December 31,

 

 

 

2006

 

2005

 

 

 

Net Income

 

Shares

 

Net Income

 

Shares

 

 

 

(Numerator)

 

(Denominator)

 

(Numerator)

 

(Denominator)

 

 

 

(restated, see Note 2)

 

 

 

 

 

 

 

Basic earnings per share factors

 

$

2,253,198

 

24,151,237

 

$

2,865,051

 

24,122,181

 

 

 

 

 

 

 

 

 

 

 

Effect of dilutive stock options

 

 

43,448

 

 

45,590

 

 

 

 

 

 

 

 

 

 

 

Diluted earnings per share factors

 

$

2,253,198

 

24,194,685

 

$

2,865,051

 

24,167,771

 

 

 

 

 

 

 

 

 

 

 

Basic earnings per share

 

$

0.09

 

 

 

$

0.12

 

 

 

Diluted earnings per share

 

$

0.09

 

 

 

$

0.12

 

 

 

 

The number of anti-dilutive weighted average shares that have been excluded in the computation of diluted earnings per share for the six months ended December 31, 2006 and 2005 were 869,804 and 871,428, respectively.

 

Note 14.  Comprehensive Income

 

The Company’s other comprehensive loss is comprised of unrealized losses on investment securities classified as available-for-sale. The components of comprehensive income and related taxes consisted of the following as of December 31, 2006 and 2005:

 

 

 

For the Three Months Ended

 

For the Six Months Ended

 

 

 

12/31/2006

 

12/31/2005

 

12/31/2006

 

12/31/2005

 

 

 

(restated, see Note 2)

 

 

 

(restated, see Note 2)

 

 

 

Other Comprehensive Income (Loss):

 

 

 

 

 

 

 

 

 

Unrealized Holding Gain (Loss) on Securities

 

$

4,615

 

$

(12,402

)

$

55,330

 

$

(81,688

)

Tax at effective rate

 

(1,846

)

4,961

 

(22,132

)

32,675

 

Total Unrealized Gain (Loss) on Securities, Net

 

2,769

 

(7,441

)

33,198

 

(49,013

)

 

 

 

 

 

 

 

 

 

 

Total Other Comprehensive Income (Loss)

 

2,769

 

(7,441

)

33,198

 

(49,013

)

Net Income

 

955,171

 

1,264,074

 

2,253,198

 

2,865,051

 

Total Comprehensive Income

 

$

957,940

 

$

1,256,633

 

$

2,286,396

 

$

2,816,038

 

 

Note 15.  Related Party Transactions

 

The Company had sales of approximately $404,000 and $169,000 during the six months ended December 31, 2006 and 2005, respectively, to a distributor (the “related party”) owned by Jeffrey Farber. Mr. Farber is a member of the Board of Directors, as well as the son of William Farber, who is the Chairman of the Board and principal shareholder of the Company.  Accounts receivable includes amounts due from the related party of approximately $91,000 and $84,000 at December 31, 2006 and 2005, respectively.  In management’s 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 Company’s 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

 

21



 

the Company.  Accordingly, the Company has treated this payment as a prepaid asset.  Arthur Bedrosian, President of the Company, Inc. was formerly the President and Chief Executive Officer and currently owns 100% of Pharmeral, Inc.  This transaction was approved by the Board of Directors of the Company and in their opinion the terms were not more favorable to the related party than they would have been to a non-related party.

 

Note 16.  Material Contract with Supplier

 

Jerome Stevens Pharmaceuticals agreement:

 

The Company’s primary finished product inventory supplier is Jerome Stevens Pharmaceuticals, Inc. (JSP), in Bohemia, New York.  Purchases of finished goods inventory from JSP accounted for approximately 69% and 61% of the Company’s inventory purchases during the three and six month periods ended December 31, 2006.  JSP accounted for 55% and 58% of finished goods inventory purchases during the three and six month periods ended December 31, 2005.  On March 23, 2004, the Company entered into an agreement with JSP for the exclusive distribution rights in the United States to the current line of JSP products, in exchange for four million (4,000,000) shares of the Company’s common stock.  The JSP products covered under the agreement included Butalbital, Aspirin, Caffeine with Codeine Phosphate capsules, Digoxin tablets and Levothyroxine Sodium tablets, sold generically and under the brand name Unithroid®.  The term of the agreement is ten years, beginning on March 23, 2004 and continuing through March 22, 2014.  Both Lannett and JSP have the right to terminate the contract if one of the parties does not cure a material breach of the contract within thirty (30) days of notice from the non-breaching party.

 

During the term of the agreement, the Company is required to use commercially reasonable efforts to purchase minimum dollar quantities of JSP’s products being distributed by the Company.  The minimum quantity to be purchased in the first year of the agreement is $15 million.  Thereafter, the minimum quantity to be purchased increases by $1 million per year up to $24 million for the last year of the ten-year contract.  The Company has met the minimum purchase requirement for the first two years of the contract, but there is no guarantee that the Company will be able to continue to do so in the future. If the Company does not meet the minimum purchase requirements, JSP’s sole remedy is to terminate the agreement.

 

Under the agreement, JSP is entitled to nominate one person to serve on the Company’s Board of Directors (the “Board”) provided, however, that the Board shall have the right to reasonably approve any such nominee in order to fulfill its fiduciary duty by ascertaining that such person was suitable for membership on the board of a publicly traded corporation. Suitability is determined by, but not limited to, the requirements of the Securities and Exchange Commission, the American Stock Exchange, and other applicable laws, including the Sarbanes-Oxley Act of 2002.  As of December 31, 2006, JSP has not exercised the nomination provision of the agreement.  The agreement was included as an Exhibit in the Current Report on Form 8-K filed by the Company on May 5, 2004, as subsequently amended.

 

Management determined that the intangible product rights asset created by this agreement was impaired as of March 31, 2005. Refer to Form 10-K dated June 30, 2006, Note 1 – Intangible Assets for additional disclosure and discussion of this impairment.

 

Other agreements:

 

In August 2005, the Company signed an agreement with a finished goods provider to purchase, at fixed prices, and distribute a certain generic pharmaceutical product in the United States.  Purchases of finished goods inventory from this provider accounted for approximately 13% and 17% of the Company’s inventory purchases during the three and six month periods ended December 31, 2006.  This provider accounted for 17% and 10% of the Company’s inventory purchases during the three and six month periods ended December 31, 2005.  The term of the agreement is three years, beginning on August 22, 2005 and continuing through August 21, 2008.

 

22



 

During the term of the agreement, the Company has committed to provide a rolling twelve month forecast of the estimated Product requirements to this provider.  The first three months of the rolling twelve month forecast are binding and constitute a firm order.

 

Note 17.  Contingencies

 

The Company monitors its compliance with all environmental laws.  Any compliance costs which may be incurred are contingent upon the results of future site monitoring and will be charged to operations when incurred. No monitoring costs were incurred during the three months ended December 31, 2006 and 2005.

 

The Company is currently engaged in several civil actions as a co-defendant with many other manufacturers of Diethylstilbestrol (“DES”), a synthetic hormone. Prior litigation established that the Company’s pro rata share of any liability is less than one-tenth of one percent. The Company was represented in many of these actions by the insurance company with which the Company maintained coverage during the time period that damages were alleged to have occurred. The insurance company denies coverage for actions alleging involvement of the Company filed after January 1, 1992. With respect to these actions, the Company paid nominal damages or stipulated to its pro rata share of any liability. The Company has either settled or is currently defending over 500 such claims. At this time, management is unable to estimate a range of loss, if any, related to these actions. Management believes that the outcome of these cases will not have a material adverse impact on the financial position or results of operations of the Company.

 

In addition to the matters reported herein, the Company is involved in litigation which arises in the normal course of business.  In the opinion of management, the resolution of these lawsuits will not have a material adverse effect on the consolidated financial position or results of operations.

 

23



 

ITEM 2.

 

MANAGEMENT’S 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 Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2006.

 

This Report on Form 10-Q and certain information incorporated herein by reference contain forward-looking statements which are not historical facts made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not promises or guarantees and investors are cautioned that all forward looking statements involve risks and uncertainties, including but not limited to the impact of competitive products and pricing, product demand and market acceptance, new product development, the regulatory environment, including without limitation, reliance on key strategic alliances, availability of raw materials, fluctuations in operating results and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission. These statements are based on management’s current expectations and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements which speak only as of the date made. Lannett is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

 

Critical Accounting Policies

 

The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amount of assets and liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities at the date of our financial statements. Actual results may differ from these estimates under different assumptions or conditions.

 

Critical accounting policies are defined as those that are reflective of significant judgments and uncertainties, and potentially result in materially different results under different assumptions and conditions. We believe that our critical accounting policies include those described below.

 

Revenue Recognition - The Company recognizes revenue when its products are shipped, and when title and risk of loss have transferred to the customer and provisions for estimates, including rebates, promotional adjustments, price adjustments, returns, chargebacks, and other potential adjustments are reasonably determinable. Accruals for these provisions are presented in the consolidated financial statements as rebates and chargebacks payable and reductions to net sales.

 

The change in the reserves for various sales adjustments may not be proportional to the change in sales because of changes in both the product mix and the customer mix. Increased sales to wholesalers will generally require additional rebates. Incentives offered to increase sales vary from product to product. Provisions for estimated rebates and promotional and other credits are estimated based on historical experience, estimated customer inventory levels, and contract terms. Provisions for other customer credits, such as price adjustments, returns, and chargebacks require management to make subjective judgments. Unlike branded innovator companies, Lannett does not use information about product levels in distribution channels from third-party sources, such as IMS Health and NDC Health, in estimating future returns and other credits. Lannett calculates a chargeback/rebate rate based on contractual terms with its customers and applies this rate to customer sales. The

 

24



 

major variable affecting this rate is customer mix, and estimates of expected customer mix are based on historical experience and sales expectations. The chargeback/rebate reserve is reviewed on a monthly basis by management using several ratios and metrics. Lannett’s methodology for estimating reserves in the three months ended December 31, 2006 has been consistent with previous periods.

 

The Company ships its products to the warehouses of its wholesale and retail chain customers. When the Company and a customer reach an agreement for the supply of a product, the customer will generally continue to purchase the product, stock its warehouse, and resell the product to its own customers. The customer will continually reorder the product as its warehouse is depleted. The Company generally has no minimum size orders for its customers. Additionally, most warehousing customers prefer not to stock excess inventory levels due to the additional carrying costs and inefficiencies created by holding excess inventory. As such, the Company’s customers continually reorder the Company’s products. It is common for the Company’s 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 manufacturer’s product is considered. Otherwise, retail prescriptions would be filled with competitors’ products. For this reason, the Company periodically offers incentives to its customers to purchase its products. These incentives are generally up-front discounts off its standard prices at the beginning of a generic campaign launch for a newly-approved or newly-introduced product, or when a customer purchases a Lannett product for the first time. Customers generally inform the Company that such purchases represent an estimate of expected resales for a period of time. This period of time is generally up to three months. The Company records this revenue, net of any discounts offered and accepted by its customers at the time of shipment. The shelf-life of the Company’s products ranges from 18 months to 36 months from the time of manufacture. The Company monitors its customers’ purchasing trends to identify any significant lapses in purchasing activity. If the Company observes a lack of recent activity, inquiries will be made to such customer regarding the success of the customer’s resale efforts. The Company attempts to minimize any potential return (or shelf life issues) by maintaining an active dialogue with the wholesale customers.

 

Chargebacks - The provision is based upon contracted prices with customers, and the accuracy of this provision is affected by changes in product sales mix and delays in selling products through distributors. This is considered the most significant and complex estimate used in the recognition of revenue. The chargeback is initiated when the Company sells its products to “indirect customers” such as independent pharmacies, managed care organizations, hospitals, nursing homes, and group purchasing organizations. The Company enters into agreements with its indirect customers to establish pricing for certain products. The indirect customers then select wholesalers from which to purchase the products at these contractual prices.

 

Upon the sale of a product to a wholesaler, the Company will estimate the chargeback provision required, based upon estimated purchases by indirect customers, each of whom may have varying contracted prices. Once the actual sale to the indirect customer occurs, the wholesaler will request a chargeback credit from the Company. The chargeback is the difference between the contractual price with the indirect customer and the wholesaler’s invoice price, if the price sold to the indirect customer is lower than the direct price to the wholesaler. The provision for chargebacks is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers. As sales increase to the large wholesale customers, such as Cardinal Health, AmerisourceBergen, and McKesson, the reserve for chargebacks will also generally increase. The size of the chargeback increase depends on the product and customer mix, as different products and customers will have different chargeback rates determined by the contractual sales prices. The Company continually monitors the reserve for chargebacks and makes adjustments as appropriate. Since the chargeback is initiated upon the transfer or sale of the product from the wholesaler to the indirect customer, there is typically a delay in processing the chargeback, based on the time to sell the product. Thus, the estimated chargeback reserve at the time of sale may vary from actual, based on this time delay and the product sales mix going through each distributor. The Company closely monitors this activity to ensure the estimates accurately reflect actual activity.

 

25



 

Rebates - Rebates are offered to the Company’s 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 certain customers to return product within a specified period prior to and subsequent to the product’s lot expiration date in exchange for a credit to be applied to future purchases. The Company’s policy requires that the customer obtain approval from the Company for any qualifying return. The Company estimates its provision for returns based on historical experience, changes to business practices, and credit terms. While such experience has allowed for reasonable estimations in the past, history may not always be an accurate indicator of future returns. The Company continually monitors the provisions for returns and makes adjustments when management believes that actual product returns may differ from established reserves. Generally, the reserve for returns increases as net sales increase. The reserve for returns is included in the rebates and chargebacks payable account on the balance sheet.

 

Other Adjustments - Other adjustments consist primarily of price adjustments, also known as “shelf stock adjustments,” which are credits issued to reflect decreases in the selling prices of the Company’s products that customers have remaining in their inventories at the time of the price reduction. Decreases in selling prices are discretionary decisions made by management to reflect competitive market conditions. Amounts recorded for estimated shelf stock adjustments are based upon specified terms with direct customers, estimated declines in market prices, and estimates of inventory held by customers. The Company regularly monitors these and other factors and evaluates the reserve as additional information becomes available. Other adjustments are included in the rebates and chargebacks payable account on the balance sheet.

 

The following tables identify the reserves for each major category of revenue allowance and a summary of the activity for the six months ended December 31, 2006 and 2005:

 

For the six months ended December 31, 2006

 

Reserve Category

 

Chargebacks

 

Rebates

 

Returns

 

Other

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

Reserve balance as of June 30, 2006

 

$

10,137,400

 

$

2,183,100

 

$

416,000

 

$

275,600

 

$

13,012,100

 

Actual credits issued related to sales recorded in prior fiscal years

 

(10,120,000

)

(1,702,800

)

(869,500

)

(219,000

)

(12,911,300

)

Reserves or (reversals) charged during Fiscal 2007 related to sales recorded in prior fiscal years

 

 

(300,000

)

460,000

 

 

160,000

 

Reserves charged to net sales during fiscal 2007 related to sales recorded in fiscal 2007

 

15,851,400

 

5,750,100

 

590,000

 

350,000

 

22,541,500

 

Actual credits issued related to sales recorded in Fiscal 2007

 

(10,065,500

)

(3,808,500

)

(254,700

)

(115,000

)

(14,243,700

)

Reserve balance as of December 31, 2006

 

$

5,803,300

 

$

2,121,900

 

$

341,800

 

$

291,600

 

$

8,558,600

 

 

26



 

For the six months ended December 31, 2005

 

Reserve Category

 

Chargebacks

 

Rebates

 

Returns

 

Other

 

Total

 

Reserve Balance as of June 30, 2005

 

$

7,999,700

 

$

1,028,800

 

$

1,692,000

 

$

29,500

 

$

10,750,000

 

Actual credits issued related to sales recorded in prior fiscal years

 

(7,100,000

)

(950,000

)

(1,450,000

)

(29,500

)

(9,529,500

)

Reserves or (reversals) charged during Fiscal 2006 related to sales recorded in prior fiscal years

 

 

 

 

 

 

Reserves charged to net sales during fiscal 2006 related to sales recorded in fiscal 2006

 

10,756,100

 

2,697,600

 

602,900

 

470,300

 

14,526,900

 

Actual credits issued related to sales recorded in Fiscal 2006

 

(3,674,300

)

(2,487,100

)

(129,400

)

(382,300

)

(6,673,100

)

Reserve Balance as of December 31, 2005

 

$

7,981,500

 

$

289,300

 

$

715,500

 

$

88,000

 

$

9,074,300

 

 

Credits issued during the quarter that relate to prior year sales are charged against the opening balance. Since reserves are assessed and recorded in aggregate, any potential additional reserves or reversals of reserves have historically offset each other. The table above shows the effects of reversals within the rebate and return categories. It is the Company’s intention that all reserves be charged to sales in the period that the sale is recognized, however, due to the nature of this estimate, it is possible that the Company may sometimes need to increase or decrease the reserve based on prior period sales. If that were to occur, management would disclose that information at that time. If the historical data the Company uses and the assumptions management makes to calculate its estimates of future returns, chargebacks, and other credits do not accurately approximate future activity, its net sales, gross profit, net income and earnings per share could change. However, management believes that these estimates are reasonable based upon historical experience and current conditions.

 

Since the Company monitors and assesses these reserves in aggregate, the rates of reserves will vary, as well as the category under which the credit falls. This variability comes about when the Company is working with indirect customers to compete with the pricing of other generic companies. The Company is currently working on improving computer systems to improve the accuracy of tracking and processing chargebacks and rebates. Improvements to automate calculation of reserves will not only reduce the potential for human error, but also will result in more in-depth analysis and improved customer interaction for resolution of open credits.

 

The rate of credits issued is monitored by the Company on a quarterly basis. The Company may change the estimate of future reserves based on the amount of credits processed, or the rate of sales made to indirect customers. The decrease of reserves to $8,559,000 at December 31, 2006 from $13,012,000 at June 30, 2006 is due to the timing of credits being processed by the customers and by the Company. Approximately 99% of the reserve balance from June 30, 2006 has been processed through December 31, 2006. Communication with wholesale customers has improved throughout Fiscal 2007. The result is that a significant amount of credits had been processed, and have reduced the liability as of December 31, 2006. Management estimates reserves based on sales mix. A comparison to wholesaler inventory reports is performed quarterly, in order to justify the balance of unclaimed chargebacks and rebates. The Company has historically found a direct correlation between the calculation of the reserve based on sales mix, and the wholesaler inventory analysis.

 

Each category of reserve shown has decreased since June 30, 2006, except for a slight increase in the other reserves. An increased level of chargebacks and rebates processed by customers and improved processing by the Company has led to this change. On a quarter to quarter basis, the chargeback reserves may fluctuate, due to the increasingly competitive generic pharmaceutical market. The increased competition in certain drugs and increase in chargebacks has resulted in decreased prices to Lannett customers. Recent quarters have seen declining net sales prices in certain products, and increases in others.

 

Accounts Receivable - The Company performs credit evaluations of its customers and adjusts credit limits based upon payment history and the customer’s current credit worthiness, as determined by a review of available credit

 

27



 

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 Company’s expectations and the provisions established, the Company cannot guarantee that it will continue to experience the same credit loss rates that it has in the past.

 

The Company also regularly monitors customer Accounts Receivable (AR) balances through a tool known as Days Sales Outstanding (“DSO”). This calculation for Net DSO begins with the Gross AR less the Rebates and Chargeback reserve. This net amount is then divided by the average daily net sales for the period. The table below shows the results of these calculations for the relevant periods:

 

 

 

Six Months ended
12/31/05

 

Fiscal Year ended
6/30/06

 

Six Months ended
12/31/06

 

Net DSO (in days)

 

48

 

68

 

74

 

Gross DSO (in days)

 

63

 

77

 

72

 

 

The Gross DSO above shows the result of the same calculation without regard to rebates and chargebacks. It is generally higher than the Net DSO calculation. The Company monitors both Net DSO and Gross DSO as an overall check on collections and reasonableness of reserves. In order to be effective indicators, both types of DSO are evaluated on a quarterly basis. The Gross DSO calculation provides management with an understanding of the frequency of customer payments, and the ability to process customer payments and deductions. The Net DSO calculation provides management with an understanding of the relationship of the A/R balance net of the reserve liability compared to net sales after reserves charged during the period.

 

The Company’s payment terms are consistent with the generic industry at 60 days for payment from all customers, including wholesalers. Net DSO for the Fiscal 2007 first quarter, net of rebates and chargebacks, increased as a result of additional sales made during the most recent period, plus an unusually low A/R balance at the end of the second quarter of Fiscal 2006, December 31, 2005. This low balance in the prior year was due to wholesale customers who had paid the balance owed to Lannett in a timely manner, but had not taken chargebacks before the balance sheet date of December 31, 2005. Thus, the reserve for chargebacks remained high as of the balance sheet date, while the A/R balance was reduced. Gross DSO has also increased since the prior year. This is primarily due to increasing sales in the latter months of the quarter. Management expects the Gross DSO calculation to approximate 60 days. Significant variances greater or less than 60 are reviewed and, if necessary, action is taken.

 

Inventories - The Company values its inventory at the lower of cost (determined by the first-in, first-out method) or market, regularly reviews inventory quantities on hand, and records a provision for excess and obsolete inventory based primarily on estimated forecasts of product demand and production requirements. The Company’s 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 Company’s inventory is determined to be overvalued, the Company would be required to recognize such costs in cost of goods sold at the time of such determination. Likewise, if inventory is determined to be undervalued, the Company may have recognized excess cost of goods sold in previous periods and would be required to recognize such additional operating income at the time of sale.

 

Stock Options - Statement of Financial Accounting Standards (“SFAS”) No. 123 (revised 2004), “Share-Based Payment,” (123(R)) was adopted effective July 1, 2005. The Company applied the standard using the modified prospective-transition method with no restatement of prior periods.  Prior to July 1, 2005, the Company accounted for those plans under the recognition and measurement provisions of APB 25, and related Interpretations, as permitted by SFAS 123. No stock-based employee compensation cost was recognized in the

 

28



 

Statement of Operations for the year ended June 30, 2005, as all options granted had an exercise price equal to the market value of the underlying common stock on the date of the grant.

 

Since the standard was applied using the modified-prospective-transition-method, prior periods have not been restated.  Under this method, the Company is required to record compensation expense for all awards granted after the date of adoption and for the unvested portion of previously granted awards that remain outstanding as of the beginning of the period of adoption.  Share-based compensation cost is measured using the Black-Scholes option pricing model. The following table highlights relevant stock-option plan information as of December 31:

 

 

 

2006

 

2005

 

Total share-based compensation expense (restated)

 

$

524,000

 

$

686,000

 

Total compensation cost related to non-vested awards not yet recognized (restated)

 

$

1,744,000

 

$

1,034,000

 

Weighted average period over which it is to be recognized

 

1.6 years

 

2.0 years

 

 

Results of Operations - Three months ended December 31, 2006 compared with three months ended December 31, 2005

 

Net sales for the three months ended December 31, 2006 (“Fiscal 2007”) increased 50% to $22,916,000 from $15,229,000 for the three months ended December 31, 2005 (“Fiscal 2006”). The increase was primarily due to greater demand for generic medication used to treat thyroid deficiency, greater demand for generic antibiotics, and new products that were approved by the FDA in the current or previous year. The Company was able to increase sales of thyroid medication through a new customer acquisition and expanded sales to existing customers. In the prior year, the thyroid medications were declining, due to a delay in the AB rating of Levothyroxine. In the current year, the increase is likely due to Lannett’s ability to provide the product quickly and cost effectively to all of our customers. The following table highlights the reasons for the increase, and the percentage each area had on the overall increase of $7,687,000:

 

Description

 

% of increase

 

Greater demand/volume

 

111

%

New product launches

 

14

%

Marketing agreements

 

38

%

Existing product changes

 

-63

%

Total

 

100

%

 

The majority of the increases are due to increased volumes. However, these increases may not be indicative of the full year sales growth. Existing product changes are also primarily driven by volume, with a small amount of decline due to pricing.

 

The existing product sales decline can be attributed to several products. Sales of products used in the treatment of epilepsy decreased by approximately $1.5 million in Fiscal 2007 because new manufacturers have entered the market, affecting sales volume. Sales of migraine headache pharmaceuticals declined $675,000. This decline can be attributed to a combination of lower product sales prices and lower volumes, a result of increased competition. Sales of drugs used in hormone replacement therapy declined nearly $100,000 in Fiscal 2007 because of greater competition and pricing pressure added by new competitors in the marketplace.

 

29



 

The Company sells its products to customers in various categories. The table below identifies the Company’s approximate net sales to each category:

 

 

 

Three Months Ended December 31,

 

Customer Category

 

2006

 

2005

 

Wholesaler/Distributor

 

$

12,393,000

 

$

10,494,000

 

Retail Chain

 

9,023,000

 

2,053,000

 

Mail-Order Pharmacy

 

1,476,000

 

1,904,000

 

Private Label

 

24,000

 

778,000

 

Total

 

$

22,916,000

 

$

15,229,000

 

 

The increase in sales to wholesaler/distributor customers is due mainly to current year improvement over prior year issues associated with Levothyroxine Sodium tablets. Excess product already at customer locations in 2005 resulted in sales declines in the quarter ended December 31, 2005. In the quarter ended December 31, 2006, the excess inventory and returns of this product were no longer an issue, and the product was again being sold on a regular basis. Retail chain sales improved over the prior year because of a new customer agreement entered during the quarter ended December 31, 2006.

 

Cost of sales (excluding amortization of intangible asset) for the second quarter of Fiscal 2007 increased 116% to $17,403,000 from $8,064,000 in Fiscal 2006. The increase is due to the 50% increase in sales which was driven mostly by volume. In addition, new product sales and marketing agreements consisted of products that have higher costs to produce or purchase. Gross profit margins (excluding amortization of intangible asset) for the second quarter of Fiscal 2007 and Fiscal 2006 were 24% and 47%, respectively. While the Company is continuously striving to keep product costs low, there can be no guarantee that profit margins will not fluctuate in future periods. Pricing pressure from competitors and costs of producing or purchasing new drugs may also fluctuate in the future. Changes in the future sales product mix may also occur. As can be seen in the mix of increased sales, the greatest increases are of products that are distributed, and not manufactured. These costs have caused the margin percentage to decrease. These changes may affect the gross profit percentage in future periods.

 

Research and development (“R&D”) expenses in the second quarter decreased 36% to $1,538,000 for Fiscal 2007 from $2,421,000 for Fiscal 2006. The decrease is primarily due to a dedicated effort to control R&D costs, while waiting for the approval from the FDA for a number of drugs. The Company expenses all production costs as R&D until the drug is approved by the FDA. R&D expenses may fluctuate from period to period, based on R&D plans for submission to the FDA.

 

Selling, general and administrative expenses in the second quarter decreased 10% to $1,982,000 in Fiscal 2007 from $2,205,000 in Fiscal 2006. The decrease is primarily due to the buildup of infrastructure in the prior year, and decreased costs of compliance with Sarbanes-Oxley. This buildup in the prior year has resulted in current year savings in consulting and other outside services. Other costs are being incurred to facilitate improvements in the Company’s infrastructure. These costs are expected to be temporary investments in the future of the Company and may not continue at the same level. However, as the Company continues to invest in technology, the Company may need to invest additional funds in technology or professional services.

 

Amortization expense for the intangible asset for the three months ended December 31, 2006 and 2005 was approximately $446,000 and $446,000, respectively. The amortization expense relates to the March 23, 2004 exclusive marketing and distribution rights agreement with JSP. For the remaining seven years of the contract, the Company will incur annual amortization expense of approximately $1,785,000.

 

The Company’s interest expense in the second quarter decreased to $68,000 in Fiscal 2007 from $85,000 in Fiscal 2006 primarily as a result of a decrease in principal balances and the refinancing of mortgage debt in

 

30



 

November 2005. Interest income in the second quarter increased to $112,000 in Fiscal 2007 from $99,000 in Fiscal 2006.

 

The Company’s income tax expense in the second quarter decreased to $637,000 in Fiscal 2007 from $843,000 in Fiscal 2006, with a 40% effective tax rate in both periods.

 

The Company reported net income of $955,000 in the second quarter of Fiscal 2007, or $0.04 basic and diluted income per share, as compared to net income of $1,264,000 in the second quarter of Fiscal 2006, or $0.05 basic and diluted income per share.

 

Results of Operations - Six months ended December 31, 2006 compared with six months ended December 31, 2005

 

Net sales for the six months ended December 31, 2006 (“Fiscal 2007”) increased 55% to $44,884,000 from $28,870,000 for the six months ended December 31, 2005 (“Fiscal 2006”). The increase was primarily due to greater demand for generic medication used to treat thyroid deficiency, greater demand for generic antibiotics, and new products that were approved by the FDA in the current or previous year. The Company was able to increase sales of thyroid medication through a new customer acquisition in the first quarter of Fiscal 2007 and to existing customers. In the prior year, the thyroid medications were declining, due to a delay in the AB rating of Levothyroxine. In the current year, the increase is due to Lannett’s ability to provide the product quickly and cost effectively to all of our customers. The following table highlights the reasons for the increase, and the percentage each area had on the overall increase of $16,014,000:

 

Description

 

% of increase

 

Greater demand/volume

 

71

%

New product launches

 

19

%

Marketing agreements

 

59

%

Existing product changes

 

-49

%

Total

 

100

%

 

 

The majority of the increases are due to increased volumes. However, these increases may not be indicative of the full year sales growth. Existing product changes are also primarily driven by volume, with a small amount of decline due to pricing.

 

The existing product sales decline can be attributed to several products. Sales of products used in the treatment of epilepsy decreased by approximately $2.2 million in Fiscal 2007 because new manufacturers have entered the market, affecting sales volume. Sales of migraine headache pharmaceuticals declined $1.4 million. This decline can be attributed to a combination of lower product sales prices, and increased competition. Sales of drugs used in hormone replacement therapy declined nearly $900,000 in Fiscal 2007 because of greater competition and pricing pressure added by new competitors in the marketplace.

 

The Company sells its products to customers in various categories. The table below identifies the Company’s approximate net sales to each category:

 

 

 

Six Months Ended December 31,

 

Customer Category

 

2006

 

2005

 

Wholesaler/Distributor

 

$

28,592,000

 

$

18,239,000

 

Retail Chain

 

13,186,000

 

5,458,000

 

Mail-Order Pharmacy

 

3,009,000

 

3,505,000

 

Private Label

 

97,000

 

1,668,000

 

Total

 

$

44,884,000

 

$

28,870,000

 

 

31



 

The increase in sales to wholesaler/distributor customers is due mainly to improvement in sales of Levothyroxine Sodium tablets. The prior year sales were affected by lower-than-expected demand and lower sales to wholesalers. In the six months ended December 31, 2006, the excess inventory and returns of this product were no longer an issue, and the product was again being sold on a regular basis. Retail Chain sales of Levothyroxine also increased, a result of a new customer acquired in the current fiscal year.

 

Cost of sales (excluding amortization of intangible asset) for the first six months increased 105% to $30,643,000 in Fiscal 2007 from $14,927,000 in Fiscal 2006. The increase is due to the 55% increase in sales which was driven mostly by volume. In addition, new product sales and marketing agreements that were entered consisted primarily of products that have higher costs to produce or purchase, increasing the cost of sales percentage. Gross profit margins (excluding amortization of intangible asset) for the first six months of Fiscal 2007 and Fiscal 2006 were 32% and 48%, respectively. While the Company is continuously striving to keep product costs low, there can be no guarantee that profit margins will not fluctuate in future periods. Pricing pressure from competitors and costs of producing or purchasing new drugs may also fluctuate in the future. Changes in the future sales product mix may also occur. These changes may affect the gross profit percentage in future periods.

 

Research and development (“R&D”) expenses in the first six months decreased 7% to $3,317,000 for Fiscal 2007 from $3,562,000 for Fiscal 2006. The decrease is primarily due to a slight decrease in production of drugs in development and preparation for submission to the FDA. The Company expenses all production costs as R&D until the drug is approved by the FDA. R&D expenses may fluctuate from period to period, based on R&D plans for submission to the FDA.

 

Selling, general and administrative expenses in the first six months increased 33% to $6,354,000 in Fiscal 2007 from $4,782,000 in Fiscal 2006. Almost the entire increase is due to $1,230,000 of expenses incurred in Fiscal 2007 that relate to marketing agreements tied to sales of new generic products. The remaining increase in expense is due to additional administrative personnel costs, related to increased headcount, professional fees and computer support fees. While the Company is focused on controlling costs, increases in personnel costs may have an ongoing, and longer lasting impact on the administrative cost structure. Other costs are being incurred to facilitate improvements in the Company’s infrastructure. These costs are expected to be temporary investments in the future of the Company and may not continue at the same level. However, as the Company continues to invest in technology, the Company may need to invest additional funds in technology or professional services.

 

Amortization expense for the intangible asset for the six months ended December 31, 2006 and 2005 was approximately $892,000 and $892,000, respectively. The amortization expense relates to the March 23, 2004 exclusive marketing and distribution rights agreement with JSP.

 

The Company’s interest expense in the first six months decreased to $132,000 in Fiscal 2007 from $193,000 in Fiscal 2006 primarily as a result of a decrease in principal balances and the refinancing of mortgage debt in November 2005. Interest income in the first six months decreased to $211,000 in Fiscal 2007 from $247,000 in Fiscal 2006.

 

The Company’s income tax expense in the first six months decreased to $1505,000 in Fiscal 2007 from $1,896,000 in Fiscal 2006, with a 40% effective tax rate in Fiscal 2007 and 39.8% effective tax rate in Fiscal 2006.

 

The Company reported net income of $2,253,000 in the first six months of Fiscal 2007, or $0.09 basic and diluted income per share, as compared to net income of $2,865,000 in the first six months Fiscal 2006, or $0.12 basic and diluted income per share.

 

Liquidity and Capital Resources

 

The Company has historically financed its operations by cash flow from operations. At December 31, 2006, working capital was $25,117,000, as compared to $22,862,000 at June 30, 2006, an increase of $1,671,000. Net cash provided by operating activities of $6,255,000 in the first six months of Fiscal 2007 is due to net income of

 

32



 

$2,253,000, and adjustments for the effects of non-cash items of $4,221,000 and decrease in operating assets and liabilities of $220,000. Significant changes in operating assets and liabilities are comprised of:

 

                  Trade accounts receivable net of rebates and chargebacks payable decreased $6,703,000 due to an increase in processing of usual and customary chargeback and rebate credits claimed by customers;

 

                  A $2,543,000 decrease in inventories resulting from increased demand for products,

 

                  A $3,846,000 increase in accounts payable due to timing of payments at the end of the month combined with increased spending on products for resale, primarily Levothyroxine Sodium tablets; and

 

                  A $1,017,000 decrease in prepaid taxes resulting from receipt of a refund on federal taxes.

 

The net cash used in investing activities of $4,523,000 for the six months ended December 31, 2006 was due to an additional $5,347,000 note receivable signed with an API provider and $1,069,000 investment in infrastructure. This was partially offset by the sale of a portion of the Company’s investment securities, which consist primarily of U. S. government and agency marketable debt securities.

 

The following table summarizes the remaining repayments of debt, including sinking fund requirements as of December 31, 2006 for the subsequent twelve month periods:

 

Twelve Month
Periods

 

Amounts Payable
to Institutions

 

2007

 

$

592,000

 

2008

 

604,000

 

2009

 

538,000

 

2010

 

4,808,000

 

2011

 

343,000

 

Thereafter

 

1,056,000

 

 

 

$

7,941,000

 

 

The Company has a $3,000,000 line of credit from Wachovia Bank, N.A. that bears interest at the prime interest rate less 0.25% (8.0% at December 31, 2006). The line of credit was renewed and extended to November 30, 2007. At December 31, 2006 and 2005, the Company had $0 outstanding under the line of credit. The line of credit is collateralized by substantially all of the Company’s assets. The Company currently has no plans to borrow under this line of credit.

 

The terms of the line of credit, the loan agreement, the related letter of credit and the 2003 Loan Financing require that the Company meet certain financial covenants and reporting standards, including the attainment of standard financial liquidity and net worth ratios. As of December 31, 2006, the Company has complied with such terms, and successfully met its financial covenants.

 

In July 2004, the Company received $500,000 of grant funding from the Commonwealth of Pennsylvania, acting through the Department of Community and Economic Development. The grant funding program requires the Company to use the funds for machinery and equipment located at their Pennsylvania locations, hire an additional 100 full-time employees by June 30, 2006, operate its Pennsylvania locations a minimum of five years and meet certain matching investment requirements. If the Company fails to comply with any of the requirements above, the Company would be liable to the full amount of the grant funding ($500,000). The Company records the unearned grant funds as a liability until the Company complies with all of the requirements of the grant funding program. On a quarterly basis, the Company will monitor its progress in fulfilling the requirements of the grant funding program and will determine the status of the liability. As of December 31, 2006, the Company has recognized the grant funding as a current liability under the caption of Unearned Grant Funds. Currently, the grant funding is recognized as a short term liability under the caption of Unearned Grant Funds, since the Company has not yet met the requirement to add 100 full-time employees. However, the

 

33



 

Company is requesting an extension of this obligation to add 100 employees, since the other requirement related to use of funds has been met already, and the requirement to operate its Pennsylvania locations is still ongoing.

 

Except as set forth in this report, the Company is not aware of any trends, events or uncertainties that have or are reasonably likely to have a material adverse impact on the Company’s short-term or long-term liquidity or financial condition.

 

Prospects for the Future

 

The Company has several generic products under development. These products are all orally-administered topical and parenteral products designed to be generic equivalents to brand named innovator drugs. The Company’s 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 Company’s records. Occasionally, the Company reviews such ANDAs to determine if the market potential for any of these older drugs has recently changed, so as to make it attractive for Lannett to reconsider manufacturing and selling it. If the Company makes the determination to introduce one of these products into the consumer marketplace, it must review the ANDA and related documentation to ensure that the approved product specifications, formulation and other factors meet current FDA requirements for the marketing of that drug. The Company would then redevelop the product and submit it to the FDA for supplemental approval. The FDA’s approval process for ANDA supplements is similar to that of a new ANDA. Generally, in these situations, the Company must file a supplement to the FDA for the applicable ANDA, informing the FDA of any significant changes in the manufacturing process, the formulation, or the raw material supplier of the previously-approved ANDA.

 

A majority of the products in development represent either previously approved ANDAs that the Company is planning to reintroduce (ANDA supplements), or new formulations (new ANDAs). The products under development are at various stages in the development cycle—formulation, scale-up, and/or clinical testing. Depending on the complexity of the active ingredient’s 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 Lannett’s developmental products will require bioequivalence studies, while others will not—depending on the FDA’s Orange Book classification. Since the Company has no control over the FDA review process, management is unable to anticipate whether or when it will be able to begin producing and shipping additional products.

 

In addition to the efforts of its internal product development group, Lannett has contracted with several outside firms for the formulation and development of several new generic drug products. These outsourced R&D products are at various stages in the development cycle — formulation, analytical method development and testing and manufacturing scale-up. These products are orally-administered solid dosage, injectables, as well as topical products intended to treat a diverse range of medical indications. It is the Company’s intention to ultimately transfer the formulation technology and manufacturing process for all of these R&D products to the Company’s own commercial manufacturing sites. The Company initiated these outsourced R&D efforts to complement the progress of its own internal R&D efforts.

 

Lannett also manufactures and sells products which are equivalent to innovator drugs which are grand-fathered, under FDA rules, prior to the passage of the Hatch-Waxman Act of 1984. The FDA allows generic manufacturers to produce and sell generic versions of such grand-fathered products by simply performing and internally documenting the product’s stability over a period of time. Under this scenario, a generic company can forego the time required for FDA ANDA approval.

 

The Company signed supply and development agreements with Olive Healthcare, of India; Orion Pharma, of Finland; Azad Pharma AG, of Switzerland, and is in negotiations with companies in Israel and Greece for similar new product initiatives, in which Lannett will market and distribute products manufactured by third parties.

 

34



 

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 Company’s R&D projects are being developed in-house under Lannett’s direct supervision and with Company personnel. Hence, the Company does not believe that its outside contracts for product development and manufacturing supply are material in nature, nor is the Company substantially dependent on the services rendered by such outside firms. Since the Company has no control over the FDA review process, management is unable to anticipate whether or when it will be able to begin producing and shipping such additional products.

 

Lannett may increase its focus on certain specialty markets in the generic pharmaceutical industry. Such a focus is intended to provide Lannett customers with increased product alternatives in categories with relatively few market participants. While there is no guarantee that Lannett has the market expertise or financial resources necessary to succeed in such a market specialty, management is confident that such future focus will be well received by Lannett customers and increase shareholder value in the long run.

 

The Company plans to enhance relationships with strategic business partners, including providers of product development research, raw materials, active pharmaceutical ingredients as well as finished goods. Management believes that mutually beneficial strategic relationships in such areas, including potential financing arrangements, partnerships, joint ventures or acquisitions, could allow for potential competitive advantages in the generic pharmaceutical market. For example, the Company has entered into prepayment arrangements in exchange for discounted purchase prices on certain active pharmaceutical ingredients (API) and oral dosage forms. The Company has also arranged for a loan to a certain API provider as well as continued funding of recent operations of this API provider that should facilitate the availability of difficult to source material in the future. The Company plans to continue to explore such areas for potential opportunities to enhance shareholder value.

 

35



 

ITEM 3.     QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

The Company has debt instruments with variable interest rates. The Equipment loan, amounting to $883,000 at December 31, 2006, bears interest at a variable rate equal to the LIBOR rate plus 150 basis points. The revenue bonds issued by the Philadelphia Authority for Industrial Development, amounting to $901,000 at December 31, 2006, bear interest at a floating rate which is equal to the minimum rate of interest necessary to sell the bonds at a price equal to the principal balance. In addition, the Company has a $3 million line of credit that bears interest at the prime interest rate less 0.25%. The Company currently has $0 outstanding under this line of credit. Loans are collateralized by inventory, accounts receivable and other assets. The agreement contains covenants with respect to working capital, net worth and certain ratios, as well as other covenants.

 

The Company invests in U.S. treasury notes, government asset-backed securities and mortgage-backed securities, all of which are exposed to interest rate fluctuations. The interest earned on these investments may vary based on fluctuations in the interest rate.

 

ITEM 4. CONTROLS AND PROCEDURES

 

 Disclosure Controls and Procedures

 

We carried out an evaluation under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934 (the “Exchange Act”), as amended for financial reporting as of December 31, 2006. As a result of the restatement described in the Explanatory Note and Note 2 to the consolidated financial statements, management has since concluded that, as of December 31, 2006, these controls and procedures were not effective to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act is recorded, processed, summarized, and reported as specified in Securities and Exchange Commission rules and forms. As a result of the restatement described in the Explanatory Note and Note 2 to the consolidated financial statements, management has since concluded that the Company did not maintain effective controls over reconciling work-in-process inventory. This control deficiency resulted in the restatement of the Company’s consolidated financial statements as of and for the three- months ended and six- months ended December 31, 2006.

 

Disclosure Control Ineffectiveness

 

During the fourth quarter of fiscal 2007, we identified a number of production orders that were completed and removed from production in our information system during fiscal 2007, however, such activity was not properly reflected in the corresponding quarterly financial statements. The result was that work in process inventory was overstated and cost of goods sold was understated by $840,000 as of and for the year ended June 30, 2007, with the following quarterly pre tax accounting effect of the misstatement as follows: three months ended September 30, 2006 was $394,000; three months ended December 31, 2006 was $158,000; and three months ended March 31, 2007 was $95,000. At the end of the period management has assessed the controls to not be effective.

 

Internal Control Over Financial Reporting Weaknesses

 

Management identified a material weakness with respect to the failure to correctly process inventory and cost of goods sold amounts in the company’s information system in addition to failure to detect such processing error

 

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through account reconciliations. Absent control improvements including improved inventory counting procedures and improved account reconciliation procedures, a material misstatement could occur in the annual financial statements as they did occur in the interim financial statements. While we have identified and implemented additional control improvements, such controls were not operating effectively at December 31, 2006.

 

We have engaged in, and continue to engage in, substantial efforts to address the material weakness in our internal control over financial reporting and the ineffectiveness of our disclosure controls and procedures.

 

The Company has remediated its material weakness through the following actions:

 

                  Including WIP in cycle counting and quarterly count procedures.  The proper execution of inventory cycle counts and period-end inventory counts will add a level of assurance that the balance is correctly stated.

                  Reconciliation of systems transactions to be performed and reviewed on a monthly basis to ensure that WIP value in inventory systems agrees to WIP value in general ledger accounts.

                  Revision of monthly closing checklist to include each trial balance account, and identify a specific person responsible for reconciling and reviewing each account as appropriate.

                  Analysis of detailed WIP inventory, and review of such analysis, to ensure the balance is reasonable in comparison to actual production activities.

                  Engage SAP consulting experts to review processes that are used to close WIP batches.

 

Changes in Internal Control Over Financial Reporting

 

There were no significant changes in the Company’s 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 Company’s most recent evaluation of its disclosure controls and procedures utilized to compile information included in this filing.

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

Regulatory Proceedings

 

The Company is engaged in an industry which is subject to considerable government regulation relating to the development, manufacturing and marketing of pharmaceutical products. Accordingly, incidental to its business, the Company periodically responds to inquiries or engages in administrative and judicial proceedings involving regulatory authorities, particularly the FDA and the Drug Enforcement Agency.

 

DES Cases

 

The Company is currently engaged in several civil actions as a co-defendant with many other manufacturers of Diethylstilbestrol (“DES”), a synthetic hormone. Prior litigation established that the Company’s pro rata share of any liability is less than one-tenth of one percent. The Company was represented in many of these actions by the insurance company with which the Company maintained coverage during the time period that damages were alleged to have occurred. The insurance company denies coverage for actions alleging involvement of the Company filed after January 1, 1992. With respect to these actions, the Company paid nominal damages or stipulated to its pro rata share of any liability. The Company has either settled or is currently defending over 500 such claims. At this time, management is unable to estimate a range of loss, if any, related to these actions.

 

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Management believes that the outcome of these cases will not have a material adverse impact on the financial position or results of operations of the Company.

 

ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K

 

(a)                          A list of the exhibits required by Item 601 of Regulation S-K to be filed as a part of this Form 10-QA is shown on the Exhibit Index filed herewith.

 

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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: October 9, 2007

By:

/s/ Brian Kearns

 

 

 

Brian Kearns

 

 

Vice President of Finance, Treasurer and

 

 

Chief Financial Officer

 

 

 

 

 

 

Dated: October 9, 2007

By:

/s/ Arthur P. Bedrosian

 

 

 

Arthur P. Bedrosian

 

 

President and Chief Executive Officer

 

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Exhibit Index

 

31.1

 

Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

Filed Herewith

 

 

 

 

 

31.2

 

Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

Filed Herewith

 

 

 

 

 

32

 

Certifications of Chief Executive Officer and Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

Filed Herewith

 

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