10-Q 1 a35531e10vq.htm FORM 10-Q Leiner Health Products Inc.
Table of Contents

 
 
FORM 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
     
þ   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 29, 2007
OR
     
o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number 333-33121
LEINER HEALTH PRODUCTS INC.
(Exact name of registrant as specified in its charter)
     
DELAWARE   95-3431709
     
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer Identification Number)
     
901 East 233rd Street, Carson, California   90745
     
(Address of principal executive offices)   (Zip Code)
(310) 835-8400
Registrant’s telephone number, including area code
N/A
(Former name or former address, if changed since last report)
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No þ
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 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 o No þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o      Accelerated filer o      Non-accelerated filer þ
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDINGS DURING THE PRECEDING FIVE YEARS:
     Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13, or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by the court. YES þ NO o
APPLICABLE ONLY TO CORPORATE ISSUERS
     Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practical date.
Common Stock, $0.01 par value, 1,000 shares outstanding as of June 30, 2007
 
*   No reports were required to be filed under Section 12, 13, or 15(d) of the Securities Exchange Act of 1934.
 
 

 


 

LEINER HEALTH PRODUCTS INC.
Report on Form 10-Q
For the Quarter Ended September 29, 2007
Table of Contents
         
       
 
       
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 EXHIBIT 31.1
 EXHIBIT 31.2
 EXHIBIT 32.1
 EXHIBIT 32.2

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Table of Contents

     
PART I   Item 1
PART I. Financial Information
Item 1. Financial Statements
Leiner Health Products Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share data)
                 
    September 29, 2007     March 31, 2007  
    (Unaudited)          
ASSETS
               
 
               
Current assets:
               
Cash and cash equivalents
  $ 8,352     $ 22,717  
Accounts receivable, net of allowances of $2,686 and $2,014 at September 29, 2007 and March 31, 2007, respectively
    48,209       66,600  
Inventories
    157,873       134,639  
Income tax receivable
    1,069       2,565  
Prepaid expenses and other current assets
    8,637       7,982  
 
           
Total current assets
    224,140       234,503  
Property, plant and equipment, net
    62,154       66,113  
Goodwill
    58,810       58,284  
Other noncurrent assets
    20,759       19,718  
 
           
Total assets
  $ 365,863     $ 378,618  
 
           
LIABILITIES AND SHAREHOLDER’S DEFICIT
               
Current liabilities:
               
Accounts payable
  $ 94,502     $ 85,875  
Accrued compensation and benefits
    8,162       8,271  
Customer allowances payable
    5,800       7,153  
Accrued interest
    5,887       5,662  
Other accrued expenses
    10,555       9,139  
Current portion of long-term debt
    6,178       5,905  
 
           
Total current liabilities
    131,084       122,005  
Long-term debt
    411,582       390,539  
Other noncurrent liabilities
    9,050       3,145  
 
           
Total liabilities
    551,716       515,689  
Commitments and contingencies
               
Shareholder’s Deficit
               
Common stock, $0.01 par value; 3,000,000 shares authorized, 1,000 shares issued and outstanding at September 29, 2007 and March 31, 2007
           
Capital in excess of par value
    13,532       13,520  
Treasury stock, 19,568 shares at cost at September 29, 2007 and March 31, 2007
    (46 )     (46 )
Accumulated deficit
    (206,666 )     (152,414 )
Accumulated other comprehensive income
    7,327       1,869  
 
           
Total shareholder’s deficit
    (185,853 )     (137,071 )
 
           
Total liabilities and shareholder’s deficit
  $ 365,863     $ 378,618  
 
           
See accompanying notes to condensed consolidated financial statements.

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Condensed Consolidated Statements of Operations
Unaudited
(in thousands)
                                 
    Three months ended     Six months ended  
    September 29,     September 30,     September 29,     September 30,  
    2007     2006     2007     2006  
Net sales
  $ 125,592     $ 197,966     $ 233,036     $ 361,876  
Cost of sales
    107,990       146,976       194,290       270,958  
 
                       
Gross profit
    17,602       50,990       38,746       90,918  
Marketing, selling and distribution expenses
    12,457       17,294       25,410       32,488  
General and administrative expenses
    15,850       10,796       31,594       20,460  
Research and development expenses
    1,072       1,096       2,530       2,177  
Amortization of other intangibles
    91       300       182       582  
Restructuring charges
    2,712             10,027        
Other operating expense
    320       1,179       320       1,112  
 
                       
Operating income (loss)
    (14,900 )     20,325       (31,317 )     34,099  
Interest expense, net
    11,066       10,110       20,705       20,155  
 
                       
Income (loss) before income taxes
    (25,966 )     10,215       (52,022 )     13,944  
Provision for income taxes
    379       4,149       1,810       5,891  
 
                       
Net income (loss)
  $ (26,345 )   $ 6,066     $ (53,832 )   $ 8,053  
 
                       
See accompanying notes to condensed consolidated financial statements.

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Condensed Consolidated Statements of Cash Flows
Unaudited
(in thousands)
                 
    Six months ended  
    September 29,     September 30,  
    2007     2006  
Operating activities
               
Net income (loss)
  $ (53,832 )   $ 8,053  
Adjustments to reconcile net income (loss) to net cash (used in) provided by operating activities:
               
Depreciation
    7,591       7,901  
Amortization of other intangibles and other contracts
    324       874  
Amortization of deferred financing charges
    1,024       971  
Restructuring charges
    10,027        
Provision for doubtful accounts and allowances
    1,600       1,953  
Provision for excess and obsolete inventory
    13,007       6,004  
Deferred income taxes
    (1,096 )      
Gain (loss) on disposal of assets
    333       (37 )
Stock option compensation expense
    12       12  
Translation adjustment
    (5,458 )     (1,153 )
Changes in operating assets and liabilities:
               
Accounts receivable
    17,665       4,690  
Inventories
    (33,795 )     (6,797 )
Income tax receivable
    1,659       3,686  
Accounts payable
    8,058       (937 )
Accrued compensation and benefits
    (329 )     76  
Customer allowances payable
    (1,440 )     2,243  
Accrued interest
    225       (4,852 )
Other accrued expenses
    (8,764 )     (1,422 )
Other current assets
    104        
Other liabilities
    5,905       901  
 
           
Net cash provided by (used in) operating activities
    (37,180 )     22,166  
 
               
Investing activities
               
Additions to property, plant and equipment
    (2,683 )     (8,732 )
Proceeds from sale of property, plant and equipment
    325        
Increase in other noncurrent assets
    (1,381 )     (482 )
 
           
Net cash used in investing activities
    (3,739 )     (9,214 )
 
               
Financing activities
               
Net borrowings (repayments) under bank revolving credit facility
    24,500       (5,000 )
Payments under bank term credit facility
    (1,200 )     (1,800 )
Increase in deferred financing charges
    (836 )      
Proceeds from the exercise of stock options
          4  
Repurchase of restricted stock
          (46 )
Net payments on capital leases and other long-term debt
    (2,097 )     (1,459 )
 
           
Net cash provided by (used in) financing activities
    20,367       (8,301 )
Effect of exchange rate changes
    6,187       1,049  
 
           
Net increase (decrease) in cash and cash equivalents
    (14,365 )     5,700  
Cash and cash equivalents at beginning of period
    22,717       7,731  
 
           
Cash and cash equivalents at end of period
  $ 8,352     $ 13,431  
 
           
See accompanying notes to condensed consolidated financial statements.

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Notes to Condensed Consolidated Financial Statements
Unaudited
1. Basis of Presentation
General
The accompanying unaudited condensed consolidated financial statements of Leiner Health Products Inc. (“Leiner” or the “Company”) consolidate all of the Company’s subsidiaries, including all of its operating subsidiaries, which are Leiner Health Products L.L.C., Leiner Health Services Corp., and Vita Health Products Inc. (“Vita Health”) and its non-operating subsidiaries, which are VH Vita Holdings Inc., Westcan Pharmaceuticals Ltd., and 6062199 Canada Inc. Such financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements.
In the opinion of management, all adjustments considered necessary for a fair presentation have been included. Such adjustments consist of adjustments of a normal recurring nature. This report should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the fiscal year ended March 31, 2007, which are included in the Company’s Annual Report on Form 10-K, on file with the Securities and Exchange Commission (“SEC”) file number 333-33121. Operating results for the three and six months ended September 29, 2007 are not necessarily indicative of the results that may be expected for the year ending March 29, 2008 or any other future periods.
There have been no material changes in the Company’s critical accounting policies and estimates during the second quarter of fiscal 2008. Accordingly, the disclosures provided in the Company’s Annual Report on Form 10-K for the year ended March 31, 2007 remains current.
Through the Company’s principal operating subsidiary, Leiner Health Products LLC, the Company received a list of Inspection Observations on Form 483 from FDA inspectors on March 16, 2007. The Form 483 contained inspection observations relating to product quality and deficiencies in the subsidiary’s compliance with good manufacturing practices, or cGMP, for OTC products manufactured, packaged or tested at our Fort Mill, South Carolina facility.
The Company believes it has implemented steps to address the observations described in the Form 483 to assure the integrity of its quality processes and OTC products. On March 20, 2007, the Company voluntarily suspended the production and distribution of all OTC products manufactured, packaged or tested at its facilities in the United States. In April 2007, as a precautionary matter, the Company voluntarily recalled all unexpired OTC products from distribution centers and wholesale warehouses in the United States.
On October 17, 2007, the FDA informed the Company that it may distribute previously manufactured OTC products that have been verified to be acceptable based on results of comprehensive independent third-party product quality assessments performed in accordance with the methodology accepted by the FDA. However, the Department of Justice is continuing its investigation of claims relating to the production, control, and distribution of certain OTC drug products at the Company’s Fort Mill facility prior to March 16, 2007. See Note 11 Contingencies for further details.
2. Fiscal Year
The Company maintains a fifty-two/fifty-three week fiscal year. The Company’s fiscal year end will fall on the last Saturday of March each year. The three months ended September 29, 2007 and September 30, 2006 were comprised of 13 and 14 weeks, respectively. The six months ended September 29, 2007 and September 30, 2006 were comprised of 26 and 27 weeks, respectively.

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Notes to Condensed Consolidated Financial Statements
Unaudited
3. Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (“SFAS 157”), which defines fair value, provides a framework for measuring fair value, and expands the disclosures required for fair value measurements. SFAS 157 applies to all accounting pronouncements that require fair value measurements. It does not require any new fair value measurements. SFAS 157 is effective for fiscal years beginning after November 15, 2007. The provisions of the SFAS 157 will be effective for the Company beginning fiscal 2009. The Company is currently evaluating the impact SFAS 157 will have on its consolidated financials upon adoption.
In February 2007, the FASB issued SFAS 159, The Fair Value Option for Financial Assets and Liabilities – Including an amendment of FASB Statement No. 115 (“SFAS 159”). SFAS 159 permits entities to choose to measure certain financial assets and liabilities at fair value. Unrealized gains and losses, arising subsequent to adoption, are reported in earnings. SFAS 159 is effective for fiscal years beginning after November 15, 2007. The provisions of SFAS 159 will be available to the Company beginning fiscal 2009 if the Company chooses to adopt such provisions.
4. Fair Values of Debt Instruments
Fair values of the Company’s debt instruments have been determined based on borrowing rates currently available to the Company for loans with similar terms or maturity. The table below provides information about the fair value of the Company’s debt obligations under the Credit Facility and Notes (in thousands):
                 
    September 29, 2007
    Total   Fair Value
Variable rate ($US)
  $ 256,700     $ 256,700  
Average interest rate
    9.60 %        
Fixed rate ($US)
  $ 150,000     $ 126,000  
Average interest rate
    11.00 %        
The fair value of the Industrial Development Revenue Bond Loan could not be estimated because there is no active market for such debt instruments.
5. Comprehensive Income (loss)
The only component of other accumulated comprehensive income (loss) is the cumulative foreign currency translation adjustment recorded in shareholder’s deficit. The comprehensive income (loss) is as follows (in thousands):
                                 
    Three months ended     Six months ended  
    September 29,     September 30,     September 29,     September 30,  
    2007     2006     2007     2006  
Net income (loss)
  $ (26,345 )   $ 6,066     $ (53,832 )   $ 8,053  
Foreign currency translation adjustment
    2,584       (1 )     5,458       1,153  
 
                       
Comprehensive income (loss)
  $ (23,761 )   $ 6,065     $ (48,374 )   $ 9,206  
 
                       
 
                               
6. Restructuring Charges
In June 2007, the Company announced plans to consolidate its manufacturing and packaging operations in the U.S. The consolidation plan called for the reduction of personnel and space at the Company’s Fort Mill, South Carolina facility by the end of September 2007. Following the consolidation, the Fort Mill facility continues to function as a distribution center. During the first six months of fiscal 2008, the Company eliminated approximately 602 positions from its Carson, Garden Grove and Valencia, California, Fort Mill, South Carolina, and Wilson, North Carolina locations. The Company continues to implement other aspects of the consolidation plan and expects to be completed by the end of fiscal 2008.

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Notes to Condensed Consolidated Financial Statements
Unaudited
(continued)
During the first six months of fiscal 2008, the Company recorded $10.0 million of restructuring charges, of which $8.9 million related to costs associated with employee terminations. Other costs included in restructuring charges related to employee retention bonuses, equipment and inventory relocation, employee relocation and other costs totaling $1.1 million.
The following table summarizes the activity and balance in the Company’s severance accrual account as it relates to costs associated with employee terminations (in thousands):
         
    Costs for  
    Employees  
    Terminated  
Balance at March 31, 2007
  $ 57  
New charges
    8,935  
Cash payments
    (3,937 )
 
     
Balance at September 29, 2007
  $ 5,055  
 
     
7. Inventories
Inventories consist of the following (in thousands):
                 
    September 29, 2007     March 31, 2007  
Inventories:
               
Raw materials, bulk vitamins and packaging materials
  $ 35,875     $ 22,181  
Work-in-process
    68,295       59,721  
Finished products
    53,703       52,737  
 
           
 
  $ 157,873     $ 134,639  
 
           
8. Debt
Long term debt consists of (in thousands):
                 
    September 29,        
    2007     March 31, 2007  
Credit Facility:
               
Revolving facility
  $ 24,500     $  
Term facility
    232,200       233,400  
 
           
Total credit facility
    256,700       233,400  
Senior subordinated notes
    150,000       150,000  
Capital lease obligations
    7,960       9,444  
Industrial development revenue bond loan
    3,100       3,600  
 
           
 
    417,760       396,444  
Less current portion
    (6,178 )     (5,905 )
 
           
Total long-term debt
  $ 411,582 )   $ 390,539  
 
           
On June 22, 2007, the Company obtained an Amendment and Waiver (the “Second Amendment”) from its senior lenders under the Credit Facility. The Second Amendment of the Credit Agreement revised the financial covenants

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Notes to Condensed Consolidated Financial Statements
Unaudited
(continued)
both in terms of applicable ratios and by allowing add-backs to EBITDA for certain cash and non-cash charges related to the restructuring of operations due to the suspension of its OTC shipments and subsequent events.
9. Income Taxes
Deferred income taxes are computed using the liability method and reflect the effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
In assessing the realizability of deferred tax assets, management considers whether it is “more likely than not” that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers taxable income in carryback years, the scheduled reversal of deferred tax liabilities, tax planning strategies, and projected future taxable income in making this assessment.
The Company recorded an income tax provision of $0.4 million or a 1.5% effective tax rate for the three months ended September 29, 2007, compared to a tax provision of $4.1 million or a 40.6% effective tax rate for the three months ended September 30, 2006. The Company recorded an income tax provision of $1.8 million or a 3.5% effective tax rate for the six months ended September 29, 2007, compared to a tax provision of $5.9 million or a 42.2% effective tax rate for the six months ended September 30, 2006.
The effective tax rate for the three and six months ended September 29, 2007 is substantially different from the effective rate for the three and six months ended September 30, 2006 primarily due to the fact that the U.S. Company recorded a full valuation allowance against its year to date operating loss. The valuation allowance on U.S. deferred tax assets was recorded due to uncertainty over the future realization of U.S. operating loss carryovers. Any additional U.S. operating loss carryovers generated in fiscal 2008 will result in further increases in the valuation allowance against U.S. deferred tax assets.
The Company adopted the provisions of FASB Interpretation 48, Accounting for Uncertainty in Income Taxes, on April 1, 2007. Previously, the Company had accounted for income tax uncertainties in accordance with Statement of Financial Accounting Standards 5, Accounting for Contingencies. As required by Interpretation 48, which clarifies Statement 109, Accounting for Income Taxes, the Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. At the adoption date, the Company applied Interpretation 48 to all material tax positions for which the statute of limitations remained open. As a result of the implementation of Interpretation 48, the Company recognized an increase of approximately $0.4 million in the liability for unrecognized tax benefits, which was accounted for as a reduction to the April 1, 2007 balance of retained earnings.
The amount of unrecognized tax benefits as of April 1, 2007, was $4.9 million which, if ultimately recognized, would reduce the Company’s annual effective tax rate. During the quarter ended September 29, 2007, the amount of unrecognized tax benefits was reduced by $0.3 million as a result of a settlement made with certain taxing authorities.
The Company is subject to income taxes in the U.S. federal jurisdiction, and various state and foreign jurisdictions. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. With few exceptions, the Company is no longer subject to U.S. federal, state, local, or non-U.S. income tax examinations by tax authorities for the years before 2003. The Company estimates that unrecognized tax benefits of approximately $1.9 million would be recognized within the next twelve months if the statute of limitation expires without the relevant taxing authorities examining the applicable returns.
The Company recognizes accrued interest and relevant penalties, if applicable, related to unrecognized tax benefits in income tax expense for all periods presented. As of April 1, 2007, the Company accrued approximately $1.2 million for the payment of interest and penalties on unrecognized tax benefits. As of September 29, 2007, the

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Notes to Condensed Consolidated Financial Statements
Unaudited
(continued)
Company has accrued an additional $0.1 million for the payment of interest and penalties on unrecognized tax benefits.
10. Share Based Compensation
2004 Option Plan
The following table summarizes the information on options outstanding as of September 29, 2007:
                                         
Outstanding   Exercisable
            Average   Weighted           Weighted
            Remaining   Average           Average
    Number of   Contractual   Exercise   Number of   Exercise
Exercise price   Shares   Life (years)   Price   Shares   Price
$2.37
    108,058       8.26     $ 2.37       33,779     $ 2.37  
The fair value of options is estimated at the date of grant using the Black-Scholes option pricing model.
The Company recorded a total expense of $2,337 and $4,674 as share-based compensation under general and administrative expense in the condensed consolidated statement of operations for the three and six months ended September 29, 2007, respectively. The Company recorded a total expense of $1,691 and $4,580 as share-based compensation under general and administrative expense in the condensed consolidated statement of operations for the three and six months ended September 30, 2006, respectively. The weighted-average per share, fair value of options granted during fiscal 2005 and fiscal 2006 was $0.35. As of September 29, 2007, there was $18,885 of total unrecorded and unrecognized compensation expense related to nonvested share-based compensation under the 2004 Option Plan. That cost is expected to be recorded and recognized over a weighted average period of 2.1 years.
Restricted Stock Plan
The following table summarizes the information on the restricted stock issued as of September 29, 2007.
                                         
Outstanding   First Call Rights Released
            Average   Weighted           Weighted
            Remaining   Average           Average
    Number of   Call Right   Purchase   Number of   Purchase
Purchase Price   Shares   Life (years)   Price   Shares   Price
$2.37
    176,108       2.75     $ 2.37       132,081     $ 2.37  
The Company recorded a total expense of $3,602 and $7,204 as share-based compensation under general and administrative expense in the condensed consolidated statement of operations for the three and six months ended September 29, 2007, respectively. The Company recorded a total expense of $3,658 and $7,660 as share-based compensation under general and administrative expense in the condensed consolidated statement of operations for the three and six months ended September 30, 2006, respectively. As of September 29, 2007, there was $39,624 of total unrecorded and unrecognized compensation expense related to the restricted stock plan. That cost is expected to be recorded and recognized over a weighted average period of 2.75 years.
11. Contingencies
The Company from time to time is engaged in litigation. The Company regularly reviews all pending litigation matters in which it is involved and established reserves deemed appropriate by management for these litigation matters. However, some of these matters are material and an adverse outcome in these matters could have a material adverse effect on its financial condition, results of operations or cash flows. The Company is vigorously defending each of these claims. The Company maintains insurance against product liability claims, but it is possible that its insurance coverage will not continue to be available on terms acceptable to the Company or that such coverage will not be adequate for liability actually incurred.

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Notes to Condensed Consolidated Financial Statements
Unaudited
(continued)
Department of Justice Investigation
On September 5, 2007, the Company became aware of a Department of Justice investigation relating to the production, control, and distribution of certain OTC drug products at the Company’s Fort Mill facility. The Company believes that the investigation concerns certain activities relating to the observations included in a Form 483 report it received from the FDA on March 16, 2007 relating to its OTC drug operations in the Company’s Fort Mill facility. The Company intends to cooperate fully with this investigation.
Breach of OTC Supply Contracts
On April 25, 2007, the Company, together with its principal operating subsidiary, Leiner Health Products LLC, received a letter confirming that Dr. Reddy’s Laboratories Limited and Dr. Reddy’s Laboratories, Inc. (together, “DRL”) were terminating the following agreements, effective immediately: OTC Distribution Agreement, dated December 4, 2002, between Leiner LLC and DRL; Famotidine Supply Agreement, dated February 15, 2001, among Dr. Reddy’s Laboratories Limited, Reddy-Cheminor, Inc., and the Company; and Supply Agreement, dated November 28, 2000, between the Company, Cheminor Drugs Limited and Reddy-Cheminor, Inc., as amended (together, the “DRL Agreements”).
The DRL Agreements provided Leiner LLC with a supply of certain active pharmaceutical ingredient and bulk tablets used to manufacture certain over-the-counter (“OTC”) products and, in the case of the OTC Distribution Agreement, exclusive access to OTC switch products developed by DRL. DRL informed the Company that it intends to enter into the Company’s OTC market by directly packaging, marketing and distributing OTC products manufactured from the active pharmaceutical ingredients and bulk tablets that it previously supplied and would have been obligated to supply to the Company under the DRL Agreements.
The Company disputes that, as contended by DRL, the receipt by its subsidiary, and the Company’s actions in response to, the list of Inspection Observations on Form 483 that was received from FDA inspectors provide any basis for DRL’s right to terminate the DRL Agreements. The Company is considering all of its alternatives in connection with DRL’s termination, including arbitration and litigation to vigorously assert its rights under the DRL Agreements. The Company may be subject to counterclaims by DRL in any arbitration or litigation and even a favorable resolution of the Company’s claims could result in distraction of its management and significant legal and other related costs.
Breach of Raw Material Supply Agreement
The Company filed a lawsuit against a supplier of chondroitin in the Superior Court in Orange County, California in June 2005. The complaint alleges breach of contract, negligence, intentional and negligent misrepresentation and other similar claims regarding the supplier’s delivery of chondroitin that the Company believes was adulterated and sub-potent. This material was not incorporated into finished products that were supplied to customers. The supplier filed a counter-claim against the Company for breach of contract and other related claims due to the Company’s refusal to pay the outstanding balance owed for the product. Following a jury trial in February 2007, the Company obtained a jury verdict in its favor for $1.28 million and against the supplier on its counter-claims. The supplier is appealing the verdict; the Company is appealing the judge ruling denying its request for attorneys’ fees. The Company recently entered into a settlement agreement pursuant to which the Company will receive $825,000 and the parties will dismiss with prejudice their respective appeals. As of September 29, 2007, the Company recorded the $825,000 in accounts receivable on the consolidated balance sheet.
Product Liability
The Company has been named as a defendant in cases alleging adverse reactions associated with the ingestion of Phenylpropanolamine containing products that the Company allegedly manufactured and sold. Currently, only two of the original 10 cases are pending; none of the cases has proceeded to trial, although the Company intends to vigorously defend these allegations if trials ensue. These actions have been tendered to the Company’s insurance carrier. The remaining eight cases have either been dismissed with prejudice or settled for non-material amounts. In the opinion of management, after consultation with legal counsel and based on currently available information, the

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Notes to Condensed Consolidated Financial Statements
Unaudited
(continued)
ultimate disposition of these matters is not expected to have a material adverse effect on our business, consolidated financial condition or results of operations.
Other Civil Litigation
From time to time, the Company is involved in other various legal proceedings arising in the ordinary course of its business operations, such as personal injury claims, employment matters, intellectual property claims and contractual disputes. While the outcome of any of these proceedings and claims cannot be predicted with certainty, management believes that it has provided adequate reserves for these claims and does not believe the outcome of any of these matters will have a material adverse effect on the Company’s consolidated financial position, results of operations or cash flows.
12. Supplemental Cash Flow Information
                 
    Six Months Ended
    September 29, 2007   September 30, 2006
    (in thousands)
Cash paid during the period ended:
               
Interest
  $ 19,632     $ 24,016  
Income taxes, net of refunds received
    (334 )     2,120  
Non cash increase in capital leases
    111       1,213  
Cash interest paid during the first six months of fiscal 2007, as compared to the same period in fiscal 2008, was higher due to the timing of interest payments, which resulted in one additional payment being made in fiscal 2007.
13. Business Segment Information
The Company operates in two business segments. One consists of the Company’s U.S. Operations (“Leiner U.S.”) and the other is the Company’s Canadian operation (“Vita Health”). The Company’s operating segments manufacture a range of vitamins, minerals and nutritional supplements (“VMS”) and OTC pharmaceuticals and distribute their products primarily through FDMC retailers. The accounting policies between the reportable segments are the same as those described in the summary of significant accounting policies. The Company evaluates segment performance based on operating profit, before the effect of non-recurring charges and gains, and inter-segment profit.

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Notes to Condensed Consolidated Financial Statements
Unaudited
(continued)
Selected financial information for the Company’s reportable segments for the three months and six months ended September 29, 2007 and September 30, 2006 is as follows (in thousands):
                         
                Consolidated
    Leiner U.S.   Vita Health   Totals
Three months ended September 29, 2007:
                       
Net sales to external customers
  $ 111,435     $ 14,157     $ 125,592  
Intersegment sales
    298       44        
Depreciation and amortization, excluding deferred financing charges
    3,558       366       3,924  
Segment operating income (loss)
    (15,802 )     902       (14,900 )
Interest expense (income), net (1)
    11,117       (51 )     11,066  
Income tax expense
    25       354       379  
Segment assets
    317,879       47,984       365,863  
Additions to property, plant and equipment
    1,273       205       1,478  
Three months ended September 30, 2006:
                       
Net sales to external customers
  $ 184,538     $ 13,428     $ 197,966  
Intersegment sales
    525       522        
Depreciation and amortization, excluding deferred financing charges
    4,055       402       4,457  
Segment operating income
    19,607       718       20,325  
Interest expense (income), net (1)
    10,071       39       10,110  
Income tax expense
    4,019       130       4,149  
Segment assets
    377,650       39,744       417,394  
Additions to property, plant and equipment
    5,897       749       6,646  
Six months ended September 29, 2007:
                       
Net sales to external customers
  $ 206,892     $ 26,144     $ 233,036  
Intersegment sales
    625       (228 )      
Depreciation and amortization, excluding deferred financing charges
    7,195       720       7,915  
Segment operating income (loss)
    (32,875 )     1,558       (31,317 )
Interest expense (income), net (1)
    20,817       (112 )     20,705  
Income tax expense
    1,213       597       1,810  
Segment assets
    317,879       47,984       365,863  
Additions to property, plant and equipment
    2,013       670       2,683  
Six months ended September 30, 2006:
                       
Net sales to external customers
  $ 336,569     $ 25,307     $ 361,876  
Intersegment sales
    1,000       1,110        
Depreciation and amortization, excluding deferred financing charges
    7,972       803       8,775  
Segment operating income
    32,814       1,285       34,099  
Interest expense (income), net (1)
    20,214       (59 )     20,155  
Income tax expense
    5,319       572       5,891  
Segment assets
    377,650       39,744       417,394  
Additions to property, plant and equipment
    8,901       1,044       9,945  
 
(1)   Interest expense, net includes the amortization of deferred financing charges.

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Notes to Condensed Consolidated Financial Statements
Unaudited
The following table sets forth the net sales of the Company’s VMS, OTC pharmaceutical and other product lines for the periods indicated (dollar amounts in thousands):
                                                                 
    Three months ended   Six months ended
    September 29,           September 30,           September 29,           September 30,    
    2007   %   2006   %   2007   %   2006   %
                         
VMS products
  $ 101.158       80 %   $ 122,338       62 %   $ 188,701       81 %   $ 222,381       61 %
OTC products (1)
    9,729       8 %     60,483       30 %     16,902       7 %     110,523       31 %
Contract manufacturing services/Other
    14,705       12 %     15,145       8 %     27,433       12 %     28,972       8 %
                         
 
Total
  $ 125,592       100 %   $ 197,966       100 %   $ 233,036       100 %   $ 361,876       100 %
                 
 
(1)   OTC product sales for the three months and six months ended September 29, 2007 primarily represent sales from the Company’s Canadian operations.
14. Financial information for subsidiary guarantor and subsidiary non-guarantor
In connection with the issuance of the 11% senior subordinated notes due 2012 (the “Notes”), the Company’s U.S. based subsidiaries, Leiner Health Services Corp. and Leiner Health Products LLC, guaranteed the payment of principal, premium and interest on the Notes. Since the Company has no independent assets or operations of its own and owns 100% of the guarantor subsidiaries, the disclosure below is presented consolidating the financial information for the Company and its subsidiary guarantors and subsidiary non-guarantors for the periods indicated.

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Condensed Consolidating Balance Sheets
Unaudited
(in thousands)
                                 
    September 29, 2007  
    Company &     Non-     Eliminations and        
    Guarantor     Guarantor     Consolidating        
    Subsidiaries     Subsidiaries     Entries     Consolidated  
ASSETS
                               
Current assets:
                               
Cash and cash equivalents
  $ 4,016     $ 4,336             $ 8,352  
Accounts receivable, net of allowances
    41,674       6,535               48,209  
Inventories
    138,572       19,301               157,873  
Income tax receivable
    (191 )     1,260               1,069  
Prepaid expenses and other current assets
    6,929       1,708               8,637  
 
                       
Total current assets
    191,000       33,140             224,140  
Intercompany receivable
    32,330       44       (32,374 )      
Property, plant and equipment, net
    52,245       9,909               62,154  
Goodwill
    55,019       3,791               58,810  
Other noncurrent assets
    19,659       1,100               20,759  
 
                       
Total assets
  $ 350,253     $ 47,984     $ (32,374 )   $ 365,863  
 
                       
LIABILITIES AND SHAREHOLDER’S DEFICIT
                               
Current liabilities:
                               
Accounts payable
  $ 89,958     $ 4,544     $     $ 94,502  
Accrued compensation and benefits
    6,532       1,630             8,162  
Customer allowances payable
    5,164       636             5,800  
Accrued interest
    5,887                   5,887  
Other accrued expenses
    9,364       1,191             10,555  
Current portion of long-term debt
    6,178                   6,178  
 
                       
Total current liabilities
    123,083       8,001             131,084  
Intercompany payable
    44       32,330       (32,374 )      
Long-term debt
    411,582                     411,582  
Other noncurrent liabilities
    9,050                     9,050  
 
                       
Total liabilities
    543,759       40,331       (32,374 )     551,716  
Shareholder’s deficit:
                               
Common stock
                       
Capital in excess of par value
    13,532                   13,532  
Treasury stock
    (46 )                 (46 )
Accumulated deficit
    (206,992 )     326             (206,666 )
Accumulated other comprehensive income
          7,327             7,327  
 
                       
Total shareholder’s deficit
    (193,506 )     7,653             (185,853 )
 
                       
Total liabilities and shareholder’s deficit
  $ 350,253     $ 47,984     $ (32,374 )   $ 365,863  
 
                       

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Condensed Consolidating Balance Sheets
Audited
(in thousands)
                                 
    March 31, 2007  
    Company &     Non-     Eliminations and        
    Guarantor     Guarantor     Consolidating        
    Subsidiaries     Subsidiaries     Entries     Consolidated  
ASSETS
                               
Current assets:
                               
Cash and cash equivalents
  $ 17,506     $ 5,211     $     $ 22,717  
Accounts receivable, net of allowances
    61,377       5,223             66,600  
Inventories
    120,918       13,721             134,639  
Income tax receivable
    1,612       953             2,565  
Prepaid expenses and other current assets
    6,650       1,332             7,982  
 
                       
Total current assets
    208,063       26,440             234,503  
Intercompany receivable
    32,652       413       (33,065 )      
Property, plant and equipment, net
    57,360       8,753             66,113  
Goodwill
    55,019       3,265             58,284  
Other noncurrent assets
    18,934       784             19,718  
 
                       
Total assets
  $ 372,028     $ 39,655     $ (33,065 )   $ 378,618  
 
                       
LIABILITIES AND SHAREHOLDER’S DEFICIT
                               
Current liabilities:
                               
Accounts payable
  $ 82,725     $ 3,150     $     $ 85,875  
Accrued compensation and benefits
    6,932       1,339             8,271  
Customer allowances payable
    6,625       528             7,153  
Accrued interest
    5,662                   5,662  
Other accrued expenses
    8,285       854             9,139  
Current portion of long-term debt
    5,895       10             5,905  
 
                       
Total current liabilities
    116,124       5,881             122,005  
Intercompany payable
    413       32,652       (33,065 )      
Long-term debt
    390,539                   390,539  
Other noncurrent liabilities
    3,145                   3,145  
 
                       
Total liabilities
    510,221       38,533       (33,065 )     515,689  
Commitments and contingencies
                               
Shareholder’s deficit:
                               
Capital in excess of par value
    13,474                   13,474  
Accumulated deficit
    (151,667 )     (747 )           (152,414 )
Accumulated other comprehensive income
          1,869             1,869  
 
                       
Total shareholder’s deficit
    (138,193 )     1,122             (137,071 )
 
                       
Total liabilities and shareholder’s deficit
  $ 372,028     $ 39,655     $ (33,065 )   $ 378,618  
 
                       

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Table of Contents

     
PART 1   Item 1
Leiner Health Products Inc.
Condensed Consolidating Statement of Operations
Unaudited
(in thousands)
                                 
    Three months ended September 29, 2007  
    Parent &     Non-     Eliminations and        
    Guarantor     Guarantor     Consolidating        
    Subsidiaries     Subsidiaries     Entries     Consolidated  
Net sales
  $ 111,733     $ 14,201     $ (342 )   $ 125,592  
Cost of sales
    97,202       11,130       (342 )     107,990  
 
                       
Gross profit
    14,531       3,071             17,602  
Marketing, selling and distribution expenses
    11,140       1,317             12,457  
General and administrative expenses
    15,060       790             15,850  
Research and development expenses
    980       92             1,072  
Amortization of other intangibles
    91                   91  
Restructuring charges
    2,712                   2,712  
Other operating expense (income)
    350       (30 )           320  
 
                       
Operating income (loss)
    (15,802 )     902             (14,900 )
Interest expense (income), net
    11,117       (51 )           11,066  
 
                       
Income (loss) before income taxes
    (26,919 )     953             (25,966 )
Provision for income taxes
    25       354             379  
 
                       
Net income (loss)
  $ (26,944 )   $ 599     $     $ (26,345 )
 
                       

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Table of Contents

     
PART 1   Item 1
Leiner Health Products Inc.
Condensed Consolidating Statement of Operations
Unaudited
(in thousands)
                                 
    Three months ended September 30, 2006  
    Parent &     Non-     Eliminations and        
    Guarantor     Guarantor     Consolidating        
    Subsidiaries     Subsidiaries     Entries     Consolidated  
Net sales
  $ 185,063     $ 13,950     $ (1,047 )   $ 197,966  
Cost of sales
    137,074       10,949       (1,047 )     146,976  
 
                       
Gross profit
    47,989       3,001             50,990  
Marketing, selling and distribution expenses
    15,954       1,340             17,294  
General and administrative expenses
    9,837       959             10,796  
Research and development expenses
    1,075       21             1,096  
Amortization of other intangibles
    300                   300  
Other operating expense (income)
    1,216       (37 )           1,179  
 
                       
Operating income
    19,607       718             20,325  
Interest expense, net
    10,071       39             10,110  
 
                       
Income before income taxes
    9,536       679             10,215  
Provision for income taxes
    4,019       130             4,149  
 
                       
Net income
  $ 5,517     $ 549     $     $ 6,066  
 
                       

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Condensed Consolidating Statement of Operations
Unaudited
(in thousands)
                                 
    Six months ended September 29, 2007  
    Parent &     Non-     Eliminations and        
    Guarantor     Guarantor     Consolidating        
    Subsidiaries     Subsidiaries     Entries     Consolidated  
Net sales
  $ 207,517     $ 25,916     $ (397 )   $ 233,036  
Cost of sales
    174,627       20,060       (397 )     194,290  
 
                       
Gross profit
    32,890       5,856             38,746  
Marketing, selling and distribution expenses
    22,914       2,496             25,410  
General and administrative expenses
    30,005       1,589             31,594  
Research and development expenses
    2,235       295             2,530  
Amortization of other intangibles
    182                   182  
Restructuring charges
    10,027                   10,027  
Other operating expense (income)
    402       (82 )           320  
 
                       
Operating income (loss)
    (32,875 )     1,558             (31,317 )
Interest expense (income), net
    20,817       (112 )           20,705  
 
                       
Income (loss) before income taxes
    (53,692 )     1,670             (52,022 )
Provision for income taxes
    1,213       597             1,810  
 
                       
Net income (loss)
  $ (54,905 )   $ 1,073     $     $ (53,832 )
 
                       

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Table of Contents

     
PART I   Item 1
Leiner Health Products Inc.
Condensed Consolidating Statement of Operations
Unaudited
(in thousands)
                                 
    Six months ended September 30, 2006  
    Parent &     Non-     Eliminations and        
    Guarantor     Guarantor     Consolidating        
    Subsidiaries     Subsidiaries     Entries     Consolidated  
Net sales
  $ 337,569     $ 26,417     $ (2,110 )   $ 361,876  
Cost of sales
    252,157       20,911       (2,110 )     270,958  
 
                       
Gross profit
    85,412       5,506             90,918  
Marketing, selling and distribution expenses
    30,040       2,448             32,488  
General and administrative expenses
    18,616       1,844             20,460  
Research and development expenses
    2,137       40             2,177  
Amortization of other intangibles
    582                   582  
Other operating expense (income)
    1,223       (111 )           1,112  
 
                       
Operating income
    32,814       1,285             34,099  
Interest expense (income), net
    20,214       (59 )           20,155  
 
                       
Income before income taxes
    12,600       1,344             13,944  
Provision for income taxes
    5,319       572             5,891  
 
                       
Net income
  $ 7,281     $ 772     $     $ 8,053  
 
                       

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Table of Contents

     
PART 1   Item 1
Leiner Health Products Inc.
Condensed Consolidating Statement of Cash Flows
Unaudited
(in thousands)
                         
    Six months ended September 29, 2007  
    Parent &     Non-        
    Guarantor     Guarantor        
    Subsidiaries     Subsidiaries     Consolidated  
Operating activities
                       
Net income (loss)
  $ (54,904 )   $ 1,072     $ (53,832 )
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
                       
Depreciation
    6,871       720       7,591  
Amortization of other intangibles and other contracts
    324             324  
Amortization of deferred financing charges
    1,024             1,024  
Restructuring charges
    10,027             10,027  
Provision for doubtful accounts and allowances
    1,586       14       1,600  
Provision for excess and obsolete inventory
    12,464       543       13,007  
Deferred income taxes
    (1,096 )           (1,096 )
Loss on disposal of assets
    327       6       333  
Stock option compensation expense
    12             12  
Translation adjustment
          (5,458 )     (5,458 )
Changes in operating assets and liabilities:
                       
Accounts receivable
    18,117       (452 )     17,665  
Inventories
    (30,118 )     (3,677 )     (33,795 )
Income tax receivable
    1,803       (144 )     1,659  
Accounts payable
    7,233       825       8,058  
Accrued compensation and benefits
    (400 )     70       (330 )
Customer allowances payable
    (1,462 )     22       (1,440 )
Accrued interest
    225             225  
Other accrued expenses
    (8,948 )     184       (8,764 )
Other current assets
    254       (150 )     104  
Other liabilities
    5,906             5,906  
 
                 
Net cash used in operating activities
    (30,755 )     (6,425 )     (37,180 )
 
Investing activities
                       
Additions to property, plant and equipment
    (2,013 )     (670 )     (2,683 )
Proceeds from sale of fixed assets
    325             325  
Decrease in other noncurrent assets
    (1,381 )           (1,381 )
 
                 
Net cash used in investing activities
    (3,069 )     (670 )     (3,739 )
 
Financing activities
                       
Net borrowings under bank revolving credit facility
    24,500             24,500  
Payments under bank term credit facility
    (1,200 )           (1,200 )
Increase in deferred financing charges
    (836 )           (836 )
Net payments on capital leases and other long-term debt
    (2,086 )     (11 )     (2,097 )
 
                 
Net cash provided by (used in) financing activities
    20,378       (11 )     20,367  
Intercompany
    (44 )     44        
Effect of exchange rate changes
          6,187       6,187  
 
                 
Net decrease in cash and cash equivalents
    (13,490 )     (875 )     (14,365 )
Cash and cash equivalents at beginning of period
    17,506       5,211       22,717  
 
                 
Cash and cash equivalents at end of period
  $ 4,016     $ 4,336     $ 8,352  
 
                 

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Table of Contents

PART I   Item 1
Leiner Health Products Inc.
Condensed Consolidating Statement of Cash Flows
Unaudited
(in thousands)
                         
    Six months ended September 30, 2006  
    Parent &     Non-        
    Guarantor     Guarantor        
    Subsidiaries     Subsidiaries     Consolidated  
Operating activities
                       
Net income
  $ 7,281     $ 772     $ 8,053  
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
                       
Depreciation
    7,098       803       7,901  
Amortization of other intangibles and other contracts
    874             874  
Amortization of deferred financing charges
    971             971  
Provision for doubtful accounts and allowances
    1,953             1,953  
Provision for excess and obsolete inventory
    5,896       108       6,004  
Gain on disposal of assets
    (36 )     (1 )     (37 )
Stock option compensation expense
    12             12  
Translation adjustment
          (1,153 )     (1,153 )
Changes in operating assets and liabilities:
                       
Accounts receivable
    4,337       353       4,690  
Inventories
    (5,711 )     (1,086 )     (6,797 )
Income tax payable
    4,559       (873 )     3,686  
Accounts payable
    (2,040 )     1,103       (937 )
Accrued compensation and benefits
    55       21       76  
Customer allowances payable
    2,240       3       2,243  
Accrued interest
    (4,783 )     (69 )     (4,852 )
Other accrued expenses
    (1,207 )     (215 )     (1,422 )
Other
    939       (38 )     901  
 
                 
Net cash provided by (used in) operating activities
    22,438       (272 )     22,166  
 
Investing activities
                       
Additions to property, plant and equipment
    (7,688 )     (1,044 )     (8,732 )
Increase in other noncurrent assets
    (482 )           (482 )
 
                 
Net cash used in investing activities
    (8,170 )     (1,044 )     (9,214 )
 
Financing activities
                       
Net borrowings under bank revolving credit facility
    (5,000 )           (5,000 )
Payments under bank term credit facility
    (1,800 )           (1,800 )
Proceeds from the exercise of stock options
    4             4  
Repurchase of restricted stock
    (46 )           (46 )
Net payments on other long-term debt
    (1,454 )     (5 )     (1,459 )
 
                 
Net cash used in financing activities
    (8,296 )     (5 )     (8,301 )
Intercompany
    450       (450 )      
Effect of exchange rate changes
          1,049       1,049  
 
                 
Net increase (decrease) in cash and cash equivalents
    6,422       (722 )     5,700  
Cash and cash equivalents at beginning of period
    3,766       3,965       7,731  
 
                 
Cash and cash equivalents at end of period
  $ 10,188     $ 3,243     $ 13,431  
 
                 

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Table of Contents

PART I   Item 2
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
As used in the management’s discussion and analysis section of this report, unless the context indicates otherwise, the terms “our company,” “we,” “our,” and “us” refer collectively to Leiner Health Products Inc. and its subsidiaries (the “Company”), including Vita Health Products Inc. of Canada (“Vita Health”), a wholly owned subsidiary.
Overview
We are the leading manufacturer of store brand vitamins, minerals and nutritional supplements (“VMS”) products and a supplier of store brand over-the-counter (“OTC”) pharmaceuticals in the U.S. food, drug and mass merchant and warehouse club (“FDMC”) retail market, as measured by U.S. retail sales in 2006. Most of our products are manufactured for our customers to sell as their own store brands. We have long-term relationships with leading FDMC retailers and focus on the fastest-growing of these retailers — the mass merchants and warehouse clubs. In addition to our primary VMS products, we provide contract manufacturing services to consumer products and pharmaceutical companies.
On October 17, 2007, the FDA informed us that we may distribute previously manufactured OTC products that are verified to be acceptable based on results of comprehensive independent third-party product quality assessments being performed in accordance with the methodology accepted by the FDA. In March 2007, we suspended production and distribution of our OTC products in all of our locations and voluntarily recalled all OTC products in April 2007.
On September 5, 2007, we became aware of a Department of Justice investigation relating to the production, control, and distribution of certain OTC drug products at the Company’s Fort Mill facility prior to March 16, 2007. The Company believes the Department of Justice is continuing its investigation. See Part II, Item 1 Legal Proceedings.
We are currently reviewing the next steps in our OTC business. We expect to begin to re-distribute certain segments of our OTC inventory beginning in the quarter ending December 2007. We are continuing our remediation efforts and expect to resume manufacturing and packaging of new OTC products once we receive concurrence from the FDA.
In June 2007, we announced plans to consolidate our manufacturing and packaging operations in the U.S. due to the interruption of our manufacturing of OTC products as complicated by the DRL contract terminations as described in our 2007 Annual Report on Form 10-K. The consolidation plan called for the closure of, and the reduction of personnel at, our Fort Mill, South Carolina facility by the end of September 2007. The Fort Mill manufacturing operations was transitioned to our Wilson, North Carolina and Garden Grove, California facilities, and its packaging operations was transitioned to our Carson, California facility. We continue to implement other aspects of the consolidation plan and expect to be completed by the end of fiscal 2008.
On June 22, 2007, we obtained an Amendment and Waiver (the “Second Amendment”) from our senior lenders under the Credit Facility. The Second Amendment of the Credit Agreement revised the financial covenants both in terms of applicable ratios and by allowing add-backs to EBITDA for certain cash and non-cash charges related to the restructuring of operations due to the suspension of our OTC shipments and subsequent events.
We operate under two separate geographical units, one in the United States and one in Canada. Our U.S. business consists of our U.S. subsidiaries, principally Leiner Health Products, LLC. Our Canadian business consists of Vita Health.
The following discussion explains significant changes in the condensed consolidated financial condition and results of our operations for the three months ended September 29, 2007 (“second quarter of fiscal 2008”) and six months ended September 29, 2007, and the significant developments affecting our financial condition since March 31, 2007. The following discussion should be read in conjunction with our audited consolidated financial statements and notes thereto for the fiscal year ended March 31, 2007, which are included in our Annual Report on Form 10-K, on file with the Securities and Exchange Commission (“SEC”).

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PART I   Item 2
Results of Operations
The following table summarizes our historical results of operations as a percentage of net sales for the three months and six months ended September 29, 2007 and September 30, 2006.
                                 
    Percentage of Net Sales (1)     Percentage of Net Sales (1)  
    Three months ended     Six months ended  
    September 29,     September 30,     September 29,     September 30,  
    2007     2006     2007     2006  
Net sales
    100.0 %     100.0 %     100.0 %     100.0 %
Cost of sales
    86.0       74.2       83.4       74.9  
 
                       
Gross profit
    14.0       25.8       16.6       25.1  
Selling, general and administrative expenses
    22.5       14.2       24.5       14.7  
Research and development expenses
    0.9       0.6       1.1       0.6  
Amortization of other intangibles
    0.1       0.2       0.1       0.2  
Restructuring charges
    2.2             4.3        
Other operating expense
    0.2       0.6             0.3  
 
                       
Operating income (loss)
    (11.9 )     10.2       (13.4 )     9.3  
Interest expense, net
    8.8       5.1       8.9       5.6  
 
                       
Income (loss) before income taxes
    (20.7 )     5.1       (22.3 )     3.7  
Provision for income taxes
    0.3       2.1       0.8       1.6  
 
                       
Net income (loss)
    (21.0 )%     3.0 %     (23.1 )%     2.1 %
 
(1)   Due to rounding, individual subtotals and totals may not recalculate.
Net Sales were $125.6 million in the second quarter of fiscal 2008, a decrease of $72.4 million, or 36.6%, from $198.0 million in the second quarter of fiscal 2007. For the first six months of fiscal 2008, net sales totaled $233.0 million, a decrease of $128.9 million, or 35.6%, from $361.9 million. Overall, approximately $55.1 million of the $72.4 million decrease in the second quarter and approximately $101.4 million of the $128.8 million decrease for the first six months of fiscal 2008 were primarily attributable to the voluntary suspension of our sales of U.S. OTC products. Additionally, the second quarter and the six months ended September 30, 2006 of the prior fiscal year included an additional week. The decrease in net sales for the second quarter of fiscal 2008 was also due to lower Vitamin, Mineral and Supplement (VMS) sales as a result of logistic challenges. For the first six months of fiscal 2008, the decrease in net sales was also due to lower sales of CoQ10, joint care and multivitamins products partially caused by logistic challenges, slightly offset by an increase in sales of fish oil products.
U.S. net sales were $111.4 million in the second quarter of fiscal 2008, a decrease of $73.1 million, or 39.6% from $184.5 million in the second quarter of fiscal 2007. For the first six months of fiscal 2008, U.S. net sales were $206.9 million, a decrease of $129.7 million, or 38.5%, from $336.6 million for the first six months of fiscal 2007. The decrease in net sales in the U.S. for the second quarter and the first six months of fiscal 2008 was primarily due to the voluntary suspension of sales of OTC products as well as logistic challenges. Net sales attributable to our Canadian operations were $14.2 million in the second quarter of fiscal 2008, an increase of $0.8 million, or 6.0%, compared to $13.4 million in the same period of fiscal 2007. For the first six months of fiscal 2008, net sales in the Canadian operations were $26.1 million, an increase of $0.8 million, or 3.2%, compared to $25.3 million for the same period of fiscal 2007. Additionally, net sales for the U.S and Canadian operations in the second quarter and the six months ended September 30, 2006 included an additional week.
Regarding our three principal product categories:
    VMS product net sales were $101.2 million in the second quarter of fiscal 2008, a decrease of $21.1 million, or 17.3%, from $122.3 million in the second quarter of fiscal 2007. During the first six months of fiscal 2008, VMS net sales were $188.7 million, a decrease of $33.7 million, or 15.2%, from $222.4 million for the first six months of fiscal 2007. Sales in the VMS category in the second quarter and the first six months of fiscal 2008 were lower due primarily to logistic challenges. In addition, the same periods in fiscal 2007 included an additional week.

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PART I   Item 2
    OTC sales activity was primarily from our Canadian operations in fiscal 2008. OTC product net sales were $9.7 million in the second quarter of fiscal 2008, a decrease of $50.8 million, or 84.0% from $60.5 million in the second quarter of fiscal 2007. During the first six months of fiscal 2008, net sales of OTC products were $16.9 million, a decrease of $93.6 million, or 84.7%, compared to $110.5 million for the first six months of fiscal 2007. The decrease in OTC net sales for the second quarter and the first six months of fiscal 2008 were primarily attributable to the voluntary suspension on sales of U.S. OTC products as a result of the FDA inspection in March 2007. In addition, the second quarter and the first six months of fiscal 2007 contained an additional week.
 
    Contract manufacturing services net sales were $14.7 million in the second quarter of fiscal 2008, a decrease of $0.4 million, or 2.6%, from $15.1 million in the second quarter of fiscal 2007. During the first six months of fiscal 2008, contract manufacturing services net sales were $27.4 million, a decrease of $1.6 million, or 5.5%, compared to $29.0 million for the first six months of fiscal 2007. The decrease in the first six months of fiscal 2008 was impacted by the suspension of sales of OTC products to our key contract manufacturing customers. Additionally, net sales on contract manufacturing services in the second quarter and the first six months of fiscal 2008 were negatively impacted due to the same periods of fiscal 2007 containing an additional week.
Cost of sales was at $108.0 million, or 86.0%, of net sales, in the second quarter of fiscal 2008, a decrease of $39.0 million, or 26.5%, from $147.0 million, or 74.2%, of net sales, in the second quarter of fiscal 2007. During the first six months of fiscal 2008, cost of sales were $194.3 million, or 83.4%, of net sales, a decrease of $76.7 million, or 28.3%, compared to $271.0 million, or 74.9%, of net sales for the same period in fiscal 2007. The increase in cost of sales as a percentage of net sales in the second quarter and the first six months of fiscal 2008 compared to the same periods of fiscal 2007 were primarily a result of costs associated with idle plant capacity due to the suspension of the manufacturing of OTC products and the establishment of additional reserves for the OTC products.
Gross profit was $17.6 million, or 14.0% of net sales, in the second quarter of fiscal 2008, a decrease of $33.4 million, or 65.5%, from $51.0 million, or 25.8% of net sales in the same period of fiscal 2007. During the six months of fiscal 2008, gross profit was $38.7 million, or 16.6% of net sales, a decrease of $52.2 million, or 57.4% from $90.9 million, or 25.1% of net sales for the same period in fiscal 2007. Gross profit as a percentage of net sales in the second quarter and the first six months of fiscal 2008 decreased as a result of lower net sales coupled with higher costs of sales due to idle plant capacity resulting from the suspension of sales of OTC products.
Selling, general and administrative expenses (“SG&A”) consist of (1) marketing, selling and distribution expenses, which include components such as advertising costs, selling costs, warehousing, shipping and handling and (2) general and administrative expenses, which include components such as administrative functions to support manufacturing activities, salaries, wages and benefit costs, travel and entertainment, professional services and facility costs. SG&A were $28.3 million, or 22.5% of net sales, in the second quarter of fiscal 2008, an increase of $0.2 million, or 0.7%, from $28.1 million, or 14.2% of net sales, in the same period in the prior year. During the first six months of fiscal 2008, SG&A were $57.0 million, or 24.5% of net sales, an increase of $4.1 million, or 7.8% of net sales, compared to $52.9 million, or 14.7% of net sales for the same period in the prior year. The increase in SG&A in fiscal 2008 was primarily due to increases in consulting and legal costs relating to the FDA observation remediation, partially offset by decreases in selling and distribution expenses related to the decrease in sales volume.
Research and development expenses (“R&D”) were $1.1 million and $2.5 million in the second quarter and the first six months of fiscal 2008, respectively, compared to $1.1 million and $2.2 million in the same periods of fiscal 2007, respectively.
Amortization of other intangibles was $0.1 million and $0.2 million in the second quarter and the first six months of fiscal 2008, respectively.
The restructuring charges in the second quarter and the first six months of fiscal year 2008 were $2.7 million and $10.0 million, respectively. Restructuring charges consist of severance and other related costs resulting from our plan to consolidate our manufacturing and packaging operations in the U.S.
Other operating expenses were $0.3 million and $0.3 million in the second quarter and the first six months of fiscal 2008, respectively, compared to $1.2 million and $1.1 million for the same periods in the prior year, respectively. Other operating expense for the second quarter and the first six months of fiscal 2008 included $0.3 million in loss on disposal of assets. Other operating expense for the second quarter and the first six months of the prior year were higher primarily due to the accrual of management fees of $1.3 million.

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PART I   Item 2
Net interest expense were $11.1 million and $20.7 million in the second quarter and the first six months of fiscal 2008, respectively, compared to $10.1 million and the $20.2 million in the same periods of the prior year, respectively. The increase in net interest expense in fiscal 2008 was primarily due to increases in outstanding indebtedness and interest rates.
We recorded an income tax provision of $0.4 million and $1.8 million in the second quarter and the first six months of fiscal 2008, respectively, compared to a provision of $4.1 million or a 40.6% effective tax rate, and $5.9 million or a 42.2% effective tax rate in the second quarter and the first six month of fiscal 2007, respectively.
Primarily as a result of factors discussed above, a net loss of $26.3 million was recorded in the second quarter of fiscal 2008 compared to a net income of $6.1 million in the first quarter of fiscal 2007. For the first six months of fiscal 2008, we recorded a net loss of $53.8 million compared to a net income of $8.1 million in the same period of the prior year.
Credit Agreement EBITDA was $26.6 million and $44.1 million for the second quarter and the first six months of fiscal 2008, respectively, compared to Credit Agreement EBITDA of $26.1 million and $44.2 million for the second quarter and the first six months of fiscal 2007. Our Credit Agreement EBITDA on a trailing twelve month basis was $95.1 million. The trailing twelve month EBITDA was calculated based on the summation of the last four fiscal quarter EBITDA amounts plus $6.2 million of EBITDA addbacks relating to quarter four of fiscal 2007 that were not included in the original EBITDA calculation. Details of the definition and calculation of the Credit Agreement EBITDA can be found under “Covenant Restrictions” and “Credit Agreement EBITDA” below.
Concentration of Credit Risk and Significant Customers, Suppliers and Products
Financial instruments, which potentially subject us to concentrations of credit risk, consist principally of trade receivables. We sell our products to a geographically diverse customer base in the FDMC retail market. We perform ongoing credit evaluations of our customers and maintain adequate reserves for potential losses.
Our top two customers accounted for the following percentage of gross sales in each respective period:
                                 
    Three months ended   Six months ended
    September 29,   September 30,   September 29,   September 30,
    2007   2006   2007   2006
Customer A
    42 %     44 %     43 %     44 %
Customer B
    25 %     25 %     25 %     24 %
Our largest customer has two retail divisions that, if viewed as separate entities, would constitute the following percentage of gross sales in each respective period:
                                 
    Three months ended   Six months ended
    September 29,   September 30,   September 29,   September 30,
    2007   2006   2007   2006
Division 1
    24 %     24 %     25 %     24 %
Division 2
    18 %     20 %     18 %     20 %
Our top ten customers in the aggregate accounted for the following percentage of gross sales in each respective period:
                                 
    Three months ended   Six months ended
    September 29,   September 30,   September 29,   September 30,
    2007   2006   2007   2006
Top ten customers
    90 %     86 %     91 %     86 %
At September 29, 2007 and March 31, 2007, we had gross receivables from two U.S. customers representing approximately 41% and 31% and 62% and 38%, respectively of total receivables.

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PART I   Item 2
For the three months and six months ended September 29, 2007 and September 29, 2006, one supplier, excluding purchases by Vita Health, provided approximately 10% of raw materials purchased. No other supplier accounted for more than 10% of our purchases for the three months and six months ended September 29, 2007.
Liquidity and Capital Resources
Our liquidity needs arise primarily from debt service on our substantial indebtedness and from the funding of our capital expenditures, ongoing operating costs and working capital.
In addition to the debt service, capital expenditure, ongoing operating costs and working capital requirements, we may have significant requirements to fund the costs associated with the Department of Justice investigation and implementation of new VMS cGMP compliance requirements.
The volume of our business has changed in the six months ended September 29, 2007, due principally to the suspension of our OTC business. Net cash used in operating activities totaled $37.2 million for the six months ended September 29, 2007, compared to net cash provided by operating activities of $22.2 million for the same period in fiscal 2007. The cash balance as of September 29, 2007, totaled $8.4 million compared to $13.4 million at September 30, 2006.
As of September 29, 2007, we had outstanding debt of an aggregate amount of $417.8 million, consisting primarily of $24.5 million in Revolver Facility, $232.2 million in principal amount under the Term Facility, $150.0 million under the Notes and an aggregate amount of $11.1 million under our other debt facilities.
Principal and interest payments under the Term Facility and the Revolving Facility, together with principal and interest payments on the Notes, represent significant liquidity requirements for us. We are required to repay the $232.2 million in term loan outstanding as of September 29, 2007 under the Credit Facility by May 27, 2011 with scheduled principal payments of $1.2 million in fiscal 2008, $2.4 million in each of fiscal 2009 through fiscal 2011, and $224.4 million in fiscal 2012. All outstanding revolving credit borrowings under the Credit Facility will become due on May 27, 2009. We are also required to repay the $150.0 million of the Notes in fiscal 2013.
On September 23, 2005, we obtained an Amendment from our senior lenders under the Credit Facility. The Amendment acknowledges the acquisition of the PFI Business for approximately $22.9 million in cash as a Permitted Acquisition. The Amendment, among other things, (a) modified the “applicable margin” rate, (b) modified existing financial and operating covenants that require, among other things, the maintenance of certain financial ratios, (c) added a new financial covenant of Minimum Liquidity (as defined) of not less than $20.0 million, and (d) modified the calculation of consolidated credit agreement EBITDA. As a condition to obtaining the consent of the lenders to the foregoing amendments, we paid an amendment fee equal to 0.25% of the aggregate total commitments of senior lenders, or approximately $0.7 million. The Amendment is effective for the quarter ended September 24, 2005 and subsequent quarters through the maturity of the Credit Facility.
On June 22, 2007, we obtained a Second Amendment from our senior lenders under the Credit Facility. The Second Amendment of the Credit Agreement revised the financial covenants both in terms of applicable ratios and by allowing add-backs to EBITDA for certain cash and non-cash charges related to the restructuring of operations due to the suspension of our OTC shipments and subsequent events. Pursuant to the Amendment, the senior lenders waived certain rights they may have had regarding any possible defaults or events of default related to such specified events. The Second Amendment also provides for an increase in the interest rates applicable under the Credit Agreement. As a condition to obtaining the consent of the lenders to the foregoing amendments, we paid an amendment fee equal to 0.25% of the aggregate total commitments of senior lenders, or approximately $0.7 million. The Second Amendment is effective for the quarter ended June 30, 2007 and subsequent quarters through the maturity of the Credit Facility. For additional details see “Covenant Restrictions” and “Credit Agreement EBITDA” below.
Borrowings under the Credit Facility bear interest at a base rate per annum plus an “applicable margin” that is fixed until March 29, 2008 and then is based on our leverage ratio and varies from 2.00% to 4.50%. We can choose a base rate of (i) ABR (Alternate base rate) or (ii) LIBOR for our Term Facility and Revolving Facility. The ABR rate is determined based on the higher of federal funds effective rate plus 0.5% or the prime commercial lending rate of UBS AG. The LIBOR rate is based on the banks prime rate and is determined based on interest periods of one, two, three or six months. Currently, the applicable margin is 4.25% for revolver borrowings and 4.50% for term loan borrowings. As of September 29, 2007, our average interest rates were 9.64% under the Credit Facility. In addition to specified agent up-front and letter of credit fees, the Credit Facility requires a commitment fee of up to 0.5% per annum of the average daily unused portion of the Revolving Facility. The Notes bear interest at a rate of 11% per annum.
At September 29, 2007, we had $24.5 million outstanding and $19.6 million available under our Revolving Facility. In accordance with our debt agreements, the $50.0 million available under the Revolving Facility has been reduced by the amount of standby letters of credit issued of approximately $5.9 million as of September 29, 2007. These letters of credit are used as security against our lease obligations and an outstanding note payable. These letters of credit expire annually and need extensions each year to various dates through 2014. The Second Amendment, among other things, requires us to maintain a Minimum Liquidity amount of not less than $10.0 million as of the last day of any fiscal month. Our Minimum Liquidity as of September 29, 2007 was $28.0 million, well above the $10 million requirement.

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PART I   Item 2
In the event the net availability under the Revolving Facility plus cash balance falls below the $10.0 million Minimum Liquidity requirement, our equity sponsors have committed to contributing to us an additional $6.5 million in equity.
Based upon current levels of operations, anticipated cost-savings and expectations as to future growth, we believe that cash generated from operations, together with amounts available under our Revolving Facility will be adequate to permit us to meet our debt service obligations, capital expenditure program requirements, ongoing operating costs and working capital needs, although no assurance can be given in this regard. We are currently engaged in reviewing additional cost-savings measures. The decisions with respect to such review may have an impact on our future financial and operating performance. Our future financial and operating performance, ability to service or refinance our debt and ability to comply with the covenants and restrictions contained in the Credit Facility, as amended, will be subject to the implementation of the results of our review, as discussed above, and future economic conditions and to financial, business and other factors, many of which are beyond our control and will be substantially dependent on the selling prices and demand for our products, raw material costs, and our ability to successfully implement our overall business and profitability strategies.
If our future cash flow from operations and other capital resources are insufficient to pay our obligations as they mature or to fund our liquidity needs, we may be forced to reduce or delay our business activities and capital expenditures, sell assets, obtain additional debt or equity capital or restructure or refinance all or a portion of our debt, including the Notes, on or before maturity. We cannot provide assurances that we would be able to accomplish any of these alternatives on a timely basis or on satisfactory terms, if at all. In addition, the terms of our existing and future indebtedness, including the Notes and Credit Facility, may limit our ability to pursue any of these alternatives.
Covenant Restrictions
The Credit Facility contains various restrictive covenants. It prohibits us from prepaying other indebtedness, including the Notes, and it requires us to satisfy certain financial condition tests and to maintain specified financial ratios, such as a minimum liquidity, maximum total leverage ratio, minimum interest coverage ratio, limitation on capital expenditures and an annual assessment of any repayment toward principal as a result of excess cash flow requirements defined in the Credit Facility. In addition, the Credit Facility prohibits us from declaring or paying any dividends and prohibits us from making any payments with respect to the Notes if we fail to perform our obligations under, or fail to meet the conditions of, the Credit Facility or if payment creates a default under the Credit Facility. The covenants under our Senior Credit Facility, and our Senior Notes may affect our ability to operate our business, may limit our ability to take advantage of business opportunities as they arise and may adversely affect the conduct of our current business. If the company elects, at its option, to make any prepayments of the Term Loans prior to June 22, 2008, a 1% premium based on the outstanding Term Loan balance is payable to the participating lenders.
The indenture governing the Notes, among other things: (1) restricts our ability and the ability of our subsidiaries to incur additional indebtedness, issue shares of preferred stock, incur liens, pay dividends or make other specified restricted payments and enter into some transactions with affiliates; (2) prohibits specified restrictions on the ability of some of our subsidiaries to pay dividends or make some payments to us; and (3) places restrictions on our ability and the ability of our subsidiaries to merge or consolidate with any other person or sell, assign, transfer, lease, convey or otherwise dispose of all or substantially all of our assets. The indenture related to these Notes and the Credit Facility also contains various covenants that limit our discretion in the operation of our businesses.
Prior to June 1, 2008, we may redeem some or all of the notes at a price equal to the principal amount plus a make-whole premium, plus accrued and unpaid interest. On or after June 1, 2008, we are entitled, at our option, to redeem all or a portion of the Senior Notes at redemption prices ranging from 100.00% to 105.50%, depending on the redemption date, plus accrued and unpaid interest.
The financial covenants in the Credit Facility specify, among other things, the following requirements as of the last day of any test period during any period set forth in the table below:

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PART I   Item 2
         
    Consolidated Indebtedness to
    Credit Agreement EBITDA (1)
Test Period   Leverage Ratio
September 29, 2007
    6.15 to 1.00  
December 29, 2007
    6.15 to 1.00  
March 29, 2008
    6.15 to 1.00  
June 28, 2008
    6.10 to 1.00  
September 27, 2008
    6.10 to 1.00  
December 27, 2008
    6.00 to 1.00  
March 28, 2009
    5.75 to 1.00  
June 28, 2009
    5.75 to 1.00  
September 27, 2009
    5.50 to 1.00  
December 27, 2009
    5.50 to 1.00  
March 28, 2010
    5.25 to 1.00  
June 28, 2010
    5.00 to 1.00  
Any Test Period Thereafter
    4.75 to 1.00  
         
    Credit Agreement EBITDA (1)
    to Consolidated
    Interest Expense Ratio
September 29, 2007
    1.60 to 1.00  
December 29, 2007
    1.60 to 1.00  
March 29, 2008
    1.60 to 1.00  
June 28, 2008
    1.60 to 1.00  
September 27, 2008
    1.60 to 1.00  
December 27, 2008
    1.60 to 1.00  
March 28, 2009
    1.65 to 1.00  
June 28, 2009
    1.70 to 1.00  
September 27, 2009
    1.75 to 1.00  
December 27, 2009
    1.80 to 1.00  
March 28, 2010
    1.90 to 1.00  
June 28, 2010
    2.00 to 1.00  
Any Test Period Thereafter
    2.15 to 1.00  
 
Note:  
 
(1) See “ — “Credit Agreement EBITDA” for more information regarding this term.
We were in compliance with all such financial covenants and have exceeded our Minimum Liquidity provision as of September 29, 2007. Our ability to comply in future periods with the financial covenants in the Credit Facility will depend on our ongoing financial and operating performance, which in turn will be subject to economic conditions and to financial, business and other factors, many of which are beyond our control and will be substantially dependent on the selling prices and demand for our products, raw material costs, and our ability to successfully implement our overall business and profitability strategies. If a violation of any of the covenants occurred, we would attempt to obtain a waiver or an amendment from our lenders, although no assurance can be given that we would be successful in this regard. The Credit Facility and the indenture governing the Notes have covenants as well as specified cross-default or cross-acceleration provisions; failure to comply with these covenants in any agreement could result in a violation of such agreement which could, in turn, lead to violations of other agreements pursuant to such cross-default or cross-acceleration provisions.
The Credit Facility is collateralized by substantially all of our assets. Borrowings under the Credit Facility are a key source of our liquidity. Our ability to borrow under the Credit Facility is dependent on, among other things, our compliance with the financial ratio covenants referred to in the preceding paragraphs. Failure to comply with the financial ratio covenants would result in a violation of the Credit Facility and, absent a waiver or amendment from the lenders under such agreement, permit the acceleration of all outstanding borrowings under the Credit Facility.

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PART I   Item 2
Credit Agreement EBITDA
The table below sets forth EBITDA as defined in the Amendment and the Second Amendment (together, the “Amendments”, which we refer to as “Credit Agreement EBITDA.” Credit Agreement EBITDA as presented below is a financial measure that is used in our Amendments. Credit Agreement EBITDA is not a defined term under U.S. generally accepted accounting principles and should not be considered as an alternative to income from operations or net income (loss) as a measure of operating results or cash flows as a measure of liquidity. Credit Agreement EBITDA is calculated by adjusting net income (loss) to exclude interest expense, depreciation and amortization, income tax expense, expenses incurred in connection with the recapitalization, aggregate amount of all other non-cash items (including non-cash compensation charges), proceeds from business interruption insurance, management fees, expenses related to any permitted acquisition (other than the PFI Acquisition), fees and expenses in connection with the exchange of the Notes, expenses incurred to the extent reimbursed by third parties pursuant to indemnification provisions, any non-cash charges outside the normal course of business that result in an accrual of a reserve for cash charges in any future period, expenses incurred or accrued representing joint care customer in-stock investments, inventory reduction impact and other expenses, expenses incurred in connection with any restructuring, expenses incurred in connection with the employment of professionals to assist restructuring, integration of the PFI Business and the Amendments, non-capitalized transition and integration expenses incurred in connection with the PFI Acquisition, any non-cash charges that result from final accounting adjustments associated with the PFI Acquisition, expenses incurred in connection with operating facilities to provide adequate inventory and to ensure continuous supplies to customers of the PFI Business, pro forma adjustments for estimated lost OTC contribution margin, expenses incurred related to our OTC remediation plans, product recalls, severance related costs and Fort Mill consolidation, our OTC inventory reserve and tangible and intangible write-down, specific litigation costs and potential acquisition costs. In addition, Credit Agreement EBITDA also adjusts net income by all non-cash items increasing consolidated net income (other than accrual of revenue or recording of receivables in the ordinary course of the business) and the reversal of any reserve or the payment of any amount that was reserved. The Credit Facility also provides for adjustments to consolidated net income including, among other things, for asset write-downs. The Amendments require us to comply with a specified debt to Credit Agreement EBITDA leverage ratio and a specified consolidated Credit Agreement EBITDA to interest expense ratio for specified periods. The specific ratios are set out under “Liquidity and Capital Resources” above.
The calculation of Credit Agreement EBITDA is set forth below (in thousands):
                                 
    Three months ended     Six months ended  
    September 29,     September 30,     September 29,     September 30,  
    2007     2006     2007     2006  
Net income (loss)
  $ (26,345 )   $ 6,066     $ (53,832 )   $ 8,053  
Provision for taxes
    379       4,149       1,810       5,891  
Interest expense, net
    11,066       10,110       20,705       20,155  
Depreciation and amortization
    3,938       4,457       7,930       8,775  
Non-cash stock compensation expense (1)
    6       5       12       12  
Management fees (2)
    75       1,344       75       1,354  
Expenses related to permitted acquisition (3)
    (8 )           (25 )      
Proceeds from business interruption insurance (4)
    (385 )           (385 )      
Restructuring charges (5)
    2,712             10,027        
Non-cash OTC related charges (6)
    8,888             8,888        
Permitted add-backs (7)
    26,290             48,905        
 
                       
Credit Agreement EBITDA
  $ 26,616     $ 26,131     $ 44,110     $ 44,240  
 
                       
 
(1)   Non-cash compensation expenses are included in the general and administrative expenses in the consolidated statement of operations and in operating activities in the consolidated statement of cash flows.
 
(2)   Management fees, which primarily include professional fees incurred in connection with the Credit Agreement, are included in other operating expenses in the consolidated statement of operations and in operating activities in the consolidated statement of cash flows.

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PART I   Item 2
 
(3)   Represents cost adjustments in connection with potential acquisition. These expenses are included in the general and administrative expenses in the consolidated statement of operations and in operating activities in the consolidated statement of cash flows.
 
(4)   Represents insurance proceeds resulting from business interruption.
 
(5)   Represents expenses incurred in connection with the Company’s plan to consolidate its manufacturing and packaging operations. These expenses are included in restructuring charges in the consolidated statement of operations for the three months and six months ended September 29, 2007.
 
(6)   Represents inventory write-down related to OTC events.
 
(7)   The Credit Amendment, and Amendments thereto, provided certain add-backs for the Company’s OTC events.
Sources and Uses of Cash
Net cash used in operating activities totaled $37.2 million in the first six months of fiscal 2008 compared to net cash provided by operating activities of $22.2 million in the first six month of fiscal 2007. In the first half of fiscal 2008, cash used in operating activities was primarily the result of operating losses of $53.8 million. Additionally, decreases in accounts receivable, resulting from lower sales volume, provided net cash flow of $17.7 million and increases in accounts payable, resulting from the extension of vendor payment terms provided net cash flows of $8.1 million. These were offset by increases in inventory, due to the build up of inventory levels to support anticipated increases in sales volume and to improve fulfillment rates, resulted in cash used of $33.8 million. The increase in other liabilities of $5.9 million was primarily due to a reclassification of certain income tax liabilities from current to non-current, hence the decrease in other accrued expenses. Net cash provided by operating activities in the first six months of fiscal 2007 was a result of operating income of $8.1 million, increases in accounts receivables of $4.7 million due to higher sales volume, partly offset by the reduction of inventory and accrued interest.
Net cash used in investing activities totaled $3.7 million and $9.2 million in the first six months of fiscal 2008 and fiscal 2007, respectively. The decrease was primarily related to lower capital expenditure in the first six months of fiscal 2008 compared to the same period of fiscal 2007. For the first six months of fiscal 2008, capital expenditures were $2.7 million compared to $8.7 million in the same period of fiscal 2007. We continue to invest in increasing our internal manufacturing capability, but we expect that our capital expenditures for fiscal 2008 will be lower than our capital expenditures in fiscal 2007. We will be investing in leasehold improvements as part of our plant consolidation.
Net cash provided by financing activities was $20.4 million in the first six months of fiscal 2008 compared to net cash used in financing activities of $8.3 million in the first six months of fiscal 2007. Net cash provided in the first six month of fiscal 2008 represents primarily the borrowings from our Revolving Facility of $24.5 million offset by payments on our Term Facility and other long-term debt and capital leases. Net cash used in the first six months of fiscal 2007 primarily represents repayment of our Revolving Facility, scheduled payments of our Term Facility and other long-term debt.
Critical Accounting Policies and Estimates
Revenue Recognition
The following table summarizes the activities in our accruals for contractual allowances, future chargebacks and product returns (in thousands):
                         
    Reserve for     Reserve for     Reserve for  
    Contractual     Future     Product  
    Allowances     Chargebacks     Returns  
Balance at March 31, 2007
  $ 7,769     $ 645     $ 2,014  
Current provision
    15,991       2,015       221  
Actual returns or credits
    (17,625 )     (2,198 )     (905 )
 
                 
Balance at September 29, 2007
  $ 6,135     $ 462     $ 1,330  
 
                 
Actual returns included products sold in prior fiscal periods of $98,000 and $372,000 for the first six months of fiscal 2008 and 2007, respectively. We do not have the ability to track actual credits for contractual allowances and future chargebacks by fiscal period because a significant time lag exists between the date on which we determine our contractual liability and when we actually pay the liability. In addition, the documentation provided to us by our

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PART I   Item 2
customers for such deductions are generally insufficient for us to determine the exact date when the liability mahy have been accrued on our balance sheet.
Forward-looking Statements
This report contains “forward-looking statements” that are subject to risks and uncertainties. These statements often include words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of such terms or similar expressions. These statements are only predictions. In addition to risks and uncertainties noted in this report, there are risks and uncertainties that could cause our actual operating results to differ materially from those anticipated by some of the statements made. Such risks and uncertainties include: (i) an FDA investigation into our OTC operations that has materially and adversely affected our operations, (ii) product recalls, (iii) failure to implement our consolidation plans on favorable terms, if at all (iv) slow or negative growth in the vitamin, mineral, supplement or over-the-counter pharmaceutical industry; (v) adverse publicity regarding the consumption of vitamins, minerals, supplements or over-the-counter pharmaceuticals; (vi) increased competition; (vii) increased costs; (viii) increases in the cost of borrowings and/or unavailability of additional debt or equity capital; (ix) changes in general worldwide economic and political conditions in the markets in which we may compete from time to time; (x) our inability to gain and/or hold market share with our customers; (xi) exposure to and expenses of defending and resolving product liability claims and other litigation; (xii) our ability to successfully implement our business strategy; (xiii) our inability to manage our operations efficiently; (ivx) consumer acceptance of our products; (vx) introduction of new federal, state, local or foreign legislation or regulation or adverse determinations by regulators; (xvi) the mix of our products and the profit margins thereon; (xvii) the availability and pricing of raw materials; and (xviii) other factors beyond our control. We expressly disclaim any obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
You should carefully consider the risks described above and in “Item 1A. — Risk Factors.” In our Annual Report on Form 10-K on file with the SEC. Any of these risks could materially and adversely affect our financial condition, results of operations or cash flows.

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Part I   Item 3
ITEM 3 Quantitative and Qualitative Disclosures about Market Risk
There have been no material changes in our market risk during the first quarter of fiscal 2008. Accordingly, the disclosure provided in the Annual Report on Form 10-K for the year ended March 31, 2007 remains current.

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Part I   Item 4
ITEM 4 Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
As of September 29, 2007, we carried out an evaluation of the effectiveness of the design and operation of our “disclosure controls and procedures” (as defined in the Securities Exchange Act of 1934 Rules 13a-15(e) and 15d-15(e)) under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer. Based upon that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that as of such date our disclosure controls and procedures are effective in alerting them, in a timely manner, to material information to be included in our periodic SEC filings.
(b) Changes in Internal Controls
There has been no significant change in our internal control over financial reporting during the quarter ended September 29, 2007 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. Our internal control over financial reporting is designed with the objective of providing reasonable assurance regarding the reliability of our financial reporting and preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
It should be noted that the design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote such conditions may be.

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PART II   Other Information
Item 1. Legal Proceedings.
We are from time to time engaged in litigation. We regularly review all pending litigation matters in which we are involved and establish reserves deemed appropriate by management for these litigation matters. However, some of these matters are material and an adverse outcome in these matters could have a material adverse effect on our financial condition, results of operations or cash flows. We are vigorously defending each of these claims. We maintain insurance against product liability claims, but it is possible that our insurance coverage will not continue to be available on terms acceptable to us or that such coverage will not be adequate for liability actually incurred.
Department of Justice Investigation
On September 5, 2007, we became aware of a Department of Justice investigation relating to the production, control, and distribution of certain OTC drug products at our Fort Mill facility. We believe the investigation concerns certain activities relating to the observations included in a Form 483 report we received from the FDA on March 16, 2007 relating to OTC drug operations in our Fort Mill facility. We intend to cooperate fully with this investigation.
Breach of OTC Supply Contracts
On April 25, 2007, we, together with our principal operating subsidiary, Leiner Health Products LLC, received a letter confirming that Dr. Reddy’s Laboratories Limited and Dr. Reddy’s Laboratories, Inc. (together, “DRL”) were terminating the following agreements, effective immediately: OTC Distribution Agreement, dated December 4, 2002, between Leiner LLC and DRL; Famotidine Supply Agreement, dated February 15, 2001, among Dr. Reddy’s Laboratories Limited, Reddy-Cheminor, Inc., and us; and Supply Agreement, dated November 28, 2000, between Cheminor Drugs Limited, Reddy-Cheminor, Inc. and us, as amended (together, the “DRL Agreements”).
The DRL Agreements provided Leiner Health Products LLC with a supply of certain active pharmaceutical ingredient and bulk tablets used to manufacture certain OTC products and, in the case of the OTC Distribution Agreement, exclusive access to OTC switch products developed by DRL. DRL informed us that it intends to enter our OTC market by directly packaging, marketing and distributing OTC products manufactured from the active pharmaceutical ingredients and bulk tablets that it previously supplied and would have been obligated to supply to us under the DRL Agreements.
We dispute that, as contended by DRL, the receipt by our subsidiary, and our actions in response to, the list of Inspection Observations on Form 483 that was received from FDA inspectors provide any basis for DRL’s right to terminate the DRL Agreements. We are considering all of our alternatives in connection with DRL’s termination, including arbitration and litigation to vigorously assert our rights under the DRL Agreements. We may be subject to counterclaims by DRL in any arbitration or litigation and even a favorable resolution of our claims could result in distraction of our management and significant legal and other related costs.
Breach of Raw Material Supply Agreement
We filed a lawsuit against a supplier of chondroitin in the Superior Court in Orange County, California in June 2005. The complaint alleges breach of contract, negligence, intentional and negligent misrepresentation and other similar claims regarding the supplier’s delivery of chondroitin that we believe was adulterated and sub-potent. This material was not incorporated into finished products that were supplied to customers. The supplier filed a counter-claim against us for breach of contract and other related claims due to our refusal to pay the outstanding balance owed for the product. Following a jury trial in February 2007, we obtained a jury verdict in our favor for $1.28 million and against the supplier on its counter-claims. The supplier is appealing the verdict; we are appealing the judge ruling denying our request for attorneys’ fees. We recently entered into a settlement agreement pursuant to which we will receive $825,000 and the parties will dismiss with prejudice their respective appeals. As of September 29, 2007, we recorded the $825,000 in accounts receivable on the consolidated balance sheet.
Product Liability
We have been named as a defendant in cases alleging adverse reactions associated with the ingestion of Phenylpropanolamine containing products that we allegedly manufactured and sold. Currently, only two of the original 10 cases are pending; none of the cases has proceeded to trial, although we intend to vigorously defend these allegations if trials ensue. These actions have been tendered to our insurance carrier. The remaining eight cases have either been dismissed with prejudice or settled for relatively small amounts. In the opinion of management,

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PART II   Other Information
after consultation with legal counsel and based on currently available information, the ultimate disposition of these matters is not expected to have a material adverse effect on our business, consolidated financial condition or results of operations.
Other Civil Litigation
From time to time, we are involved in other various legal proceedings arising in the ordinary course of our business operations, such as personal injury claims, employment matters, intellectual property claims and contractual disputes. While the outcome of any of these proceedings and claims cannot be predicted with certainty, management believes that it has provided adequate reserves for these claims and does not believe the outcome of any of these matters will have a material adverse effect on our consolidated financial position, results of operations or cash flows.
Item 1A. Risk Factors.
In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended March 31, 2007. If any of these risks occur, our business, prospects, financial condition, operating results and cash flows could be materially adversely affected. There are no material changes from the 10-K Risk Factors.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
    Not applicable
Item 3. Defaults Upon Senior Securities.
    Not applicable
Item 4. Submission of Matters to a Vote of Security Holders.
    Not applicable
Item 5. Other Information.
    None
Item 6. Exhibits.
31.1   Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended
 
31.2   Certification of Executive Vice Present and Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended
 
32.1   Certification of Chief Executive Officer, pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
 
32.2   Certification of Executive Vice President and Chief Financial Officer, pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
         
  Leiner Health Products Inc.
 
 
Date: November 13, 2007  By:   /s/ Kevin McDonnell    
    Kevin McDonnell   
    Executive Vice President and Chief Financial Officer   

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EXHIBIT INDEX
31.1   Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended
 
31.2   Certification of Executive Vice Present and Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended
 
32.1   Certification of Chief Executive Officer, pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
 
32.2   Certification of Executive Vice President and Chief Financial Officer, pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

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