-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, UjGW11symfKV03sXzY3napdRJ/TsAXo6fRgjwaLkvXl3H0c0iywIhDb3TrbudCLU lqYc6DyX2knemrv97ZS/Qw== 0000891092-04-005010.txt : 20041022 0000891092-04-005010.hdr.sgml : 20041022 20041022170346 ACCESSION NUMBER: 0000891092-04-005010 CONFORMED SUBMISSION TYPE: 8-K/A PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20040810 ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041022 DATE AS OF CHANGE: 20041022 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BRADLEY PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000864268 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 222581418 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K/A SEC ACT: 1934 Act SEC FILE NUMBER: 001-31680 FILM NUMBER: 041092390 BUSINESS ADDRESS: STREET 1: 383 RTE 46 WEST CITY: FAIRFIELD STATE: NJ ZIP: 08816 BUSINESS PHONE: 9738821505 MAIL ADDRESS: STREET 1: 383 ROUTE 46 WEST CITY: FAIRFIELD STATE: NJ ZIP: 08816 8-K/A 1 e19367_8ka.htm FORM 8-K/A

SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549


FORM 8-K/A

AMENDMENT NO. 1 to

CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) of the

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): August 10, 2004

BRADLEY PHARMACEUTICALS, INC.
(Exact name of registrant as specified in charter)

Delaware 0-18882 22-2581418
(State or other jurisdiction of
 incorporation)
(Commission File Number) (IRS Employer
Identification No.)

383 Route 46 West, Fairfield, New Jersey 07004
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (973) 882-1505

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 
   

 


 

Explanatory Note:

Bradley Pharmaceuticals, Inc. filed a Form 8-K on August 12, 2004 announcing that it had, through its wholly-owned subsidiary BDY Acquisition Corp., completed the acquisition on August 10, 2004 of certain assets constituting the “Bioglan business” from Bioglan Pharmaceuticals Company, Quintiles Bermuda Ltd. and Quintiles Ireland Limited, each a subsidiary of Quintiles Transnational Corp. The purpose of this amendment is to file various financial statements relating to the Bioglan business.

Item 9.01 (Formerly Item 7) - Financial Statements and Exhibits.

(a) Financial statements of business acquired.

     The audited balance sheets of the Bioglan business as of December 31, 2003 and 2002, and the related audited statements of operations, entity equity and cash flows for the periods from March 22, 2002 through December 31, 2002, January 1, 2003 through September 25, 2003 and September 26, 2003 through December 31, 2003, are attached hereto as Exhibit 99.2 and incorporated herein by reference.

     The audited balance sheet of the Bioglan business as of August 10, 2004, and the related audited statements of operations, entity equity and cash flows for the period from January 1, 2004 through August 10, 2004, are attached hereto as Exhibit 99.3 and incorporated herein by reference.

     The unaudited balance sheet of the Bioglan business as of June 30, 2004, and the related unaudited statements of operations, entity equity and cash flows for the six months ended June 30, 2004 and 2003, are attached hereto as Exhibit 99.4 and incorporated herein by reference.

     For a discussion regarding the omission of the required audited statements of income and cash flows of the Bioglan business for periods prior to March 22, 2002, see Item 7(a) of the Form 8-K filed by Bradley on August 12, 2004 to which this amendment relates.

(b) Pro forma financial information.

     The unaudited pro forma condensed consolidated balance sheet of Bradley as of June 30, 2004, the unaudited pro forma condensed consolidated income statement of Bradley for the six months ended June 30, 2004 and the unaudited pro forma condensed consolidated income statement of Bradley for the year ended December 31, 2003 are attached hereto as Exhibit 99.5 and incorporated herein by reference.

(c) Exhibits.

     The following exhibits are filed pursuant to Item 601 of Regulation S-K:

No.
Description
2.1* Asset Purchase Agreement, dated June 8, 2004, by and between Bradley Pharmaceuticals, Inc., Bioglan Pharmaceuticals Company, Quintiles Transnational Corp., Quintiles Bermuda Ltd. and Quintiles Ireland Limited.

 
  2 

 


 

2.2* First Amendment to Asset Purchase Agreement, dated August 10, 2004, by and between Bradley Pharmaceuticals, Inc., Bioglan Pharmaceuticals Company, Quintiles Transnational Corp., Quintiles Bermuda Ltd. and Quintiles Ireland Limited.

23.1 Consent of PricewaterhouseCoopers LLP, independent auditors.

99.1* Press release dated August 10, 2004.

99.2 Audited balance sheets of the Bioglan business as of December 31, 2003 and 2002 and related audited statements of operations, entity equity and cash flows for the periods from March 22, 2002 through December 31, 2002, January 1, 2003 through September 25, 2003 and September 26, 2003 through December 31, 2003.

99.3 Audited balance sheet of the Bioglan business as of August 10, 2004 and related audited statements of operations, entity equity and cash flows for the period from January 1, 2004 through August 10, 2004.

99.4 Unaudited balance sheet of the Bioglan business as of June 30, 2004 and related unaudited statements of operations, entity equity and cash flows for the six months ended June 30, 2004 and 2003.

99.5 Unaudited pro forma condensed consolidated balance sheet of Bradley at and as of June 30, 2004, pro forma condensed consolidated income statement of Bradley for the six months ended June 30, 2004 and pro forma condensed consolidated income statement of Bradley for the year ended December 31, 2003.

*   Previously filed

 
  3 

 


 

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 hereunto duly authorized.

  BRADLEY PHARMACEUTICALS, INC.

  By: /s/ R. Brent Lenczycki
R. Brent Lenczycki, CPA
Chief Financial Officer and
Vice President

Dated: October 22, 2004

 
  4 

 


 

EXHIBIT LIST

No.
Description
2.1* Asset Purchase Agreement, dated June 8, 2004, by and between Bradley Pharmaceuticals, Inc., Bioglan Pharmaceuticals Company, Quintiles Transnational Corp., Quintiles Bermuda Ltd. and Quintiles Ireland Limited.

2.2* First Amendment to Asset Purchase Agreement, dated August 10, 2004, by and between Bradley Pharmaceuticals, Inc., Bioglan Pharmaceuticals Company, Quintiles Transnational Corp., Quintiles Bermuda Ltd. and Quintiles Ireland Limited.

23.1 Consent of PricewaterhouseCoopers LLP, independent auditors.

99.1* Press release dated August 10, 2004.

99.2 Audited balance sheets of the Bioglan business as of December 31, 2003 and 2002 and related audited statements of operations, entity equity and cash flows for the periods from March 22, 2002 through December 31, 2002, January 1, 2003 through September 25, 2003 and September 26, 2003 through December 31, 2003.

99.3 Audited balance sheet of the Bioglan business as of August 10, 2004 and related audited statements of operations, entity equity and cash flows for the period from January 1, 2004 through August 10, 2004.

99.4 Unaudited balance sheet of the Bioglan business as of June 30, 2004 and related unaudited statements of operations, entity equity and cash flows for the six months ended June 30, 2004 and 2003.

99.5 Unaudited pro forma condensed consolidated balance sheet of Bradley at and as of June 30, 2004, pro forma condensed consolidated income statement of Bradley for the six months ended June 30, 2004 and pro forma condensed consolidated income statement of Bradley for the year ended December 31, 2003.

*   Previously filed

 
  5 

 


  EX-23.1 2 e19367ex23_1.htm CONSENT OF AUDITORS

EXHIBIT 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

     We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (No. 333-75997), Form S-3 (No. 333-74724), Form S-3 (No. 333-108596), Form S-8 (333-75382) and on Form S-8 (No. 333-112456) of Bradley Pharmaceuticals, Inc. of our reports dated July 16, 2004 and September 21, 2004 relating to the financial statements of Bioglan Pharmaceutical Operations of Quintiles Transnational Corp., which appear in this Current Report on Form 8-K/A of Bradley Pharmaceuticals, Inc. dated October 22, 2004.

/s/ PricewaterhouseCoopers LLP

Raleigh, NC
October 19, 2004

 
   

 


  EX-99.2 3 e19367ex99_2.htm FINANCIAL STATEMENTS

EXHIBIT 99.2

Bioglan Pharmaceutical
Operations of
Quintiles Transnational Corp.
Financial Statements
December 31, 2003 and 2002

 
   

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

CONTENTS

Page(s)

Reports of Independent Auditors   1- 2
     
Financial Statements    
     
Balance Sheets   3
     
Statements of Operations   4
     
Statements of Entity Equity   5
     
Statements of Cash Flows   6
     
Notes to Financial Statements   7 -19


   

 


 

[LETTERHEAD OF PRICEWATERHOUSECOOPERS LLP]

Report of Independent Auditors

To the Board of Directors of Quintiles Transnational Corp.:

In our opinion, the accompanying balance sheet and the related statements of operations, of entity equity and of cash flows present fairly, in all material respects, the financial position of the Bioglan Pharmaceutical Operations of Quintiles Transnational Corp. (the “Entity”) at December 31, 2003, and the results of its operations and its cash flows for the period from September 26, 2003 through December 31, 2003 in conformity with accounting principles generally accepted in the United States of America. These financial statements are the responsibility of the Entity’s management. Our responsibility is to express an opinion on these financial statements based on our audit. We conducted our audit of these statements in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

The Entity was part of Quintiles Transnational Corp. (“Quintiles”) and consequently, as discussed in Notes A.1 and A.2, these financial statements have been derived from the accounting records of Quintiles and reflect certain assumptions and allocations. Moreover, as discussed in Note A.2, the Entity relied on Quintiles for certain administrative, management and other services. Accordingly, these financial statements do not necessarily reflect the financial position, results of operations and cash flows of the Entity had it been a stand-alone entity.

/s/ PricewaterhouseCoopers LLP

July 16, 2004

 
  1 

 


 

[LETTERHEAD OF PRICEWATERHOUSECOOPERS LLP]

Report of Independent Auditors

To the Board of Directors of Quintiles Transnational Corp.:

In our opinion, the accompanying balance sheet and the related statements of operations, of entity equity and of cash flows present fairly, in all material respects, the financial position of the Bioglan Pharmaceutical Operations of Quintiles Transnational Corp. (the “Entity”) at December 31, 2002, and the results of its operations and its cash flows for the periods from January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002 in conformity with accounting principles generally accepted in the United States of America. These financial statements are the responsibility of the Entity’s management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

The Entity was part of Quintiles Transnational Corp. (“Quintiles”) and consequently, as discussed in Notes A.1 and A.2, these financial statements have been derived from the accounting records of Quintiles and reflect certain assumptions and allocations. Moreover, as discussed in Note A.2, the Entity relied on Quintiles for certain administrative, management and other services. Accordingly, these financial statements do not necessarily reflect the financial position, results of operations and cash flows of the Entity had it been a stand-alone entity.

/s/ PricewaterhouseCoopers LLP

July 16, 2004

 
  2 

 


 

Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

BALANCE SHEETS

  December 31,
ASSETS 2003     2002
  Successor
    Predecessor
CURRENT ASSETS        
Cash and cash equivalents $   1,540,721     $        29,123
  Accounts receivable - net of allowances 2,469,781     3,164,672
  Prepaid and other assets 566,570     541,356
  Inventories 3,880,399     2,113,712
     
   
    Total current assets 8,457,471     5,848,863
Property and equipment, net 879,639     533,620
Goodwill 530,458    
Intangible assets, net 78,651,624     60,242,856
Other assets 5,604    
     
   
  Total Assets   $ 88,524,796     $ 66,625,339
     
   
LIABILITIES AND ENTITY EQUITY        
             
CURRENT LIABILITIES        
  Accounts payable $   1,413,435     $   1,349,217
  Accrued expenses 3,536,313     5,295,760
  Capital lease obligations, current portion 16,667    
     
   
    Total current liabilities 4,966,415     6,644,977
LONG-TERM LIABILITIES        
Capital lease obligations, less current portion 41,218    
Due to affiliates 22,767,167     30,458,682
COMMITMENTS AND CONTINGENCIES        
ENTITY EQUITY          
  Contributed capital 49,685,601     28,316,485
  Accumulated other comprehensive income 3,706,976     1,065,304
  Retained earnings 7,357,419     139,891
     
   
      60,749,996     29,521,680
     
   
  Total Liabilities and Entity Equity $88,524,796     $66,625,339
     
   
The accompanying notes are an integral part of these financial statements.

 
  3 

 


 

Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

STATEMENTS OF OPERATIONS

  September 26,
2003 through
December 31,
2003

  January 1, 2003
through
September 25,
2003

  March 22, 2002
through
December 31,
2002

 
  Successor   Predecessor   Predecessor  
             
Net sales $18,901,495   $33,892,244   $22,269,207  
             
Cost of sales, exclusive of depreciation and amortization 4,768,935   8,157,837   6,176,417  
Selling, general and administrative expenses 6,355,473   15,786,603   12,857,738  
Management fee and cost share fee 124,456   349,297   285,303  
Depreciation and amortization 2,584,036   4,392,194   2,540,590  
 
 
 
 
      Total cost of sales and operating expenses 13,832,900   28,685,931   21,860,048  
 
 
 
 
      Income from operations 5,068,595   5,206,313   409,159  
 
 
 
 
Interest expense (income), net 118,150   63,494   (5,255 )
Foreign currency (gain) loss (3,265,609 ) (62,830 ) 28,196  
 
 
 
 
      Other (income) expense, net (3,147,459 ) 664   22,941  
 
 
 
 
      Income before income tax expense 8,216,054   5,205,649   386,218  
Income tax expense 858,635   786,725   246,327  
 
 
 
 
      NET INCOME $  7,357,419   $   4,418,924   $      139,891  
 
 
 
 
The accompanying notes are an integral part of these financial statements.

 
  4 

 


 

Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

STATEMENTS OF ENTITY EQUITY

    Contributed
Capital

Retained
Earnings

Comprehensive
Income

Accumulated
Other
Comprehensive Income

Total
Predecessor:
Balance at March 22, 2002
  $                 —   $             —       $                   —   $                   —
Capital contribution   28,316,485         28,316,485
 Net income     139,891   $       139,891     139,891
 Foreign currency adjustment       1,065,304   1,065,304   1,065,304
           
       
Comprehensive income for the period from
March 22, 2002 through December 31, 2002
      $    1,205,195    
   
 
 
 
 
Balance at December 31, 2002   28,316,485   139,891     1,065,304     29,521,680
Capital contribution   154,470         154,470
Net income     4,418,924   $    4, 418,924     4, 418,924
 Foreign currency adjustment       3,751,275   3,751,275   3, 751,275
           
       
Comprehensive income for the period from
January 1, 2003 through September 25, 2003
      $    8,170,199    
   
 
 
 
 
Balance at September 25, 2003   $28,470,955   $ 4,558,815       $    4,816,579   $ 37,846,349
   
 
 
 
 
Successor:                    
Balance at September 26, 2003   $               —   $               —       $                —   $                —
Capital contribution   49,685,601         49,685,601
Net income     7,357,419   $    7,357,419     7,357,419
Foreign currency adjustment       3,706,976   3,706,976   3,706,976
           
       
Comprehensive income for the period from
September 26, 2003 through December 31, 2003
      $ 11,064,395    
   
 
 
 
 
Balance at December 31, 2003   $49,685,601   $ 7,357,419       $ 3,706,976   $ 60,749,996
   
 
     
 
The accompanying notes are an integral part of these financial statements.

 
  5 

 


 

Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

STATEMENTS OF CASH FLOWS

      September 26,
2003 through
December 31,
2003

January 1,
2003 through
September 25,
2003

March 22, 2002
through
December 31,
2002

  Successor Predecessor   Predecessor 
           

 

Cash flows from operating activities:          

 

    Net income $     7,357,419   $4,418,924   $     139,891  
  Adjustments to reconcile net income to net cash          
      provided by operating activities:            
    Depreciation 100,697   208,237   205,016  
    Amortization 2,483,339   4,183,957   2,335,574  
    Allowance for doubtful accounts   24,175   50,745  
    Changes in operating assets and liabilities:            
      Accounts receivable (1,864,664 ) 2,535,380   (1,178,801 )
      Inventories 1,966,555   (3,733,242 ) (157,991 )
    Prepaid expenses and other assets (145,470 ) 114,653   (184,752 )
    Accounts payable 1,000,930   (936,712 ) 580,845  
    Other payables     (400,000 )
    Accrued expenses 1,224,453   (3,146,901 ) 2,335,392  
 
 
 
 
Net cash provided by operating activities 12,123,259   3,668,471   3,725,919  
             
Cash flows from investing activities:            
  Purchase of property and equipment (76,334 ) (513,494 ) (218,115 )
  Acquisition of trademarks, licenses, etc.     (28,525,725 )
 
 
 
 
Net cash (used in) investing activities (76,334 ) (513,494 ) (28,743,840 )
             
Cash flows from financing activities:            
  Payment of capital contributions   154,470   28,316,484  
  Funding from affiliate (10,856,463 ) (3,024,294 ) (3,270,036 )
  Repayments of capital lease obligations (6,395 ) (845 )  
 
 
 
 
Net cash (used in) provided by financing activities (10,862,858 ) (2,870,669 ) 25,046,448  
               
  Effect of foreign currency exchange rate
     changes on cash
20,988   22,235   596  
               
  INCREASE IN CASH AND CASH  EQUIVALENTS 1,205,055   306,543   29,123  
             
Cash and cash equivalents at beginning of period 335,666   29,123    
 
 
 
 
Cash and cash equivalents at end of period $    1,540,721   $    335,666   $        29,123  
 
 
 
 
Supplemental disclosures of cash flow information:            
  Cash paid during the period for:          

 

    Interest $               —   $            —   $              —

 

    Income taxes $               —   $            —   $              —

 

           

 

Non-cash Investing and Financing Activities:          

 

  Push down goodwill and other intangibles $11,839,252   $            —   $              —

 

  Acquisition of property and equipment under
     capital leases
$        34,699   $    30,426   $              —

 


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

 
  6 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

NOTE A – ORGANIZATION, NATURE OF ENTITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

1. The Entity

The primary business activity of the Bioglan Pharmaceutical Operations of Quintiles Transnational Corp. is the marketing of various dermatology pharmaceutical products, which have been primarily acquired through the purchase or license of trademark rights and patents. These operations are a combination of Quintiles Transnational Corp.’s wholly-owned subsidiary, Bioglan Pharmaceuticals Company, and certain activities conducted at Quintiles Transnational Corp.’s wholly-owned subsidiaries in Ireland and Bermuda (collectively referred to as “Bioglan” or the “Entity”).

A summary of the significant accounting policies of the Entity applied in the preparation of the accompanying financial statements follows:

2. Basis of Presentation

The financial statements for the Entity include the accounts of Bioglan Pharmaceuticals Company and certain accounts from Quintiles Bermuda, Inc. and Bioglan Dublin, Ltd. (a foreign sales corporation). The business units in the preceding sentence are wholly-owned subsidiaries of Quintiles Transnational Corp., the “Parent.” All inter-entity transactions have been eliminated.

The accompanying financial statements present on a historical basis the financial position, results of operations, changes in equity and cash flows for all periods presented and reflect the “carve out” of the Entity from the consolidated financial statements of Quintiles Transnational Corp.

Transfers of operating funds between the Entity and the Parent, and the Parent’s various business units occur primarily on a noninterest-bearing basis, with the net amount of these transfers reflected as due to affiliates in the accompanying financial statements. The net balance in due to affiliates at December 31, 2003 and 2002, of $22,767,167 and $30,458,682, respectively, is classified as a due to affiliates in the accompanying balance sheets. At December 31, 2003, the Entity has an intercompany note payable denominated in Canadian dollars totaling C$20,000,000 (US$15,454,000) with an annual interest rate of 3% and another non-interest bearing note denominated in Singapore dollars totaling S$50,446,920 (US$29,617,387). There were no intercompany notes payable at December 31, 2002. This amount in included in the due to affiliates caption in the accompanying balance sheet.

The Parent performed certain limited services and incurred certain costs for the Entity. Services provided include business development, marketing, finance, and human resources. The costs of the services provided by the Parent have been allocated to the Entity based upon the ratio of net sales of the Entity to the total of the Parent’s consolidated net revenues for certain costs and based upon the Entity’s headcount to the Parent’s consolidated headcount for others. Costs allocated to the Entity for these services are included in the management fee and cost share fee caption in the accompanying statements of operations. In the opinion of management, the method of allocating these costs is believed to be reasonable. However, expenses allocated to the Entity are not necessarily indicative of the expenses that would have been incurred on a stand alone basis nor are they indicative of costs that may be charged or incurred in the future.

On September 25, 2003 the Entity’s Parent completed a merger transaction pursuant to which the Parent was acquired by a subsidiary of a newly formed holding company, Pharma Services Holding, Inc. (“Pharma Services”). Pharma Services accounted for the transaction using the purchase method of accounting and therefore allocated the purchase price to the fair values of the Parent’s assets and liabilities on the date of purchase. The purchase accounting related to the September 2003 transaction has been pushed down to the Entity’s separate financial statements. Accordingly, as of September 26, 2003, the Entity has been presented on an entirely new basis of accounting, the Entity’s operations have been identified as predecessor and successor and, where appropriate, separated with a vertical black line.

 
  7 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

3. Use of Estimates

In preparing financial statements in conformity with accounting principles generally accepted in the United States of America, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and net sales and expenses during the reporting period. Actual results could differ from those estimates. Some of the more significant estimates for the Entity’s financial statements relate to chargebacks, rebates, discounts and returns, and the determination of useful lives of intangible assets.

4. Fair Value of Financial Instruments

The carrying value of cash equivalents, accounts receivable, accounts payable and accrued expenses at December 31, 2003 and 2002 approximate their fair value due to the short-term nature of these items.

5. Cash and Cash Equivalents

The Entity considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash is comprised of funds held in accounts at commercial banks.

6. Accounts Receivable and Significant Customers

The Entity extends credit on an uncollateralized basis primarily to wholesale drug distributors. Historically, the Entity has not experienced significant credit losses related to its customer accounts. The Entity’s two largest customers accounted for an aggregate of approximately 85% and 82% of accounts receivable at December 31, 2003, and 2002, respectively. On December 31, 2003, Customer A owed approximately $2,717,450 to the Entity or 56% of accounts receivable and Customer B owed approximately $1,411,510 to the Entity or 29% of accounts receivable. On December 31, 2002, Customer A owed approximately $1,650,243 or 35% of accounts receivable and Customer B owed approximately $2,173,183 or 47% of accounts receivable to the Entity. The following table presents a summary of sales to significant customers as a percentage of the Entity’s net sales:

Customer   September 26, 2003
through
December 31, 2003

Successor
January 1, 2003
through
September 25, 2003

Predecessor
March 22, 2002
through
December 31, 2002

Predecessor
A 36% 48% 35%
B 46% 29% 31%
C 5% 17% 18%

Supplemental information on the accounts receivable balances at December 31, 2003 and 2002 are as follows:

    2003
Successor

2002
Predecessor

Trade accounts receivable $4,873,404 $4,667,236
Less allowances:
Chargebacks/Rebates 232,431 70,877
Returns 2,000,000 1,293,631
Discounts 96,272 87,311
Doubtful accounts 74,920 50,745
   
 
 
2,403,623 1,502,564
   
 
 
Accounts receivable, net of allowances $2,469,781 $3,164,672
   
 
 

Trade receivables consist of amounts receivable for sales of product primarily to wholesale customers.

 
  8 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

7. Allowances for returns, chargebacks, rebates, discounts and doubtful accounts

The Entity’s return policy typically allows customers to return products during an eighteen-month window beginning six months prior to the expiration date of each product and up to twelve months after the expiration date. The Entity believes that it has sufficient data to estimate future returns over the return time period at the time of sale. The Entity is required to estimate the level of sales which will ultimately be returned pursuant to the Entity’s return policy and record a related allowance at the time of sale. These amounts are deducted from the Entity’s gross sales to determine net sales. The Entity’s estimates take into consideration historical returns of a given product, product specific information provided by the Entity’s customers and information obtained regarding the levels of inventory being held by the Entity’s customers, as well as overall purchasing patterns by its customers. The Entity periodically reviews the allowance established for returns and adjusts it based on actual experience. If the Entity over or under estimates the level of sales that will ultimately be returned, there could be a material impact to the Entity’s financial statements.

Chargebacks are based on the difference between the prices at which the Entity sells its products to wholesalers and the sales price ultimately paid by the end-user (often governmental agencies and managed care buying groups) pursuant to fixed price contracts. The Entity records an estimate of the amount to be charged back to the Entity at the time of sale to the wholesaler. Management estimates its allowances for chargebacks, based upon factors including current contract prices, historical chargeback rates and actual chargebacks claimed. The amount of actual chargebacks claimed may differ from the amounts accrued by the Entity.

The Entity establishes and maintains rebate allowances for amounts payable to managed care organizations and state Medicaid programs for the reimbursement of a portion of the retail price of prescriptions filled that are covered by the respective plans. The amounts estimated to be paid relating to products sold are recognized as revenue reductions on a quarterly basis based on the Entity’s best estimate of the expected prescription fill rate to these managed care patients using historical experience adjusted to reflect known changes in the factors that impact such allowances.

The Entity records an estimate of the prompt payment discount amount deducted from customer’s payments at the time of sale. Typically, the Entity offers a 2% discount based upon prompt customer payments. Management estimates its allowance for discounts, based upon historical discounts claimed. The amount of actual discounts claimed may differ from the amounts accrued by the Entity.

The Entity also maintains a provision for doubtful accounts, when the Entity believes the probability of collecting the accounts receivable is remote, based upon a specific analysis of the Entity’s accounts. The amount of actual customer defaults could differ (either higher or lower) from the amounts accrued by the Entity.

8. Inventories

The Entity purchases certain raw materials and packaging components from third-party manufacturing vendors. The Entity also utilizes third parties to manufacture and package finished goods held for sale. The Entity takes title to finished goods inventories once manufactured and warehouses such goods until final distribution and sale. Inventories are carried on the books at the lower of cost or market. The Entity provides a reserve for estimated obsolescence or unmarketable inventory, based on a specific identification method, in an amount equal to the cost of the inventory. The Entity uses the first-in-first-out method to remove costs from inventory.

 
  9 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

Supplemental information on inventory balances at December 31, 2003 and 2002 are as follows:

    2003
Successor

2002
Predecessor

                               
Finished goods $ 4,203,936 $ 2,326,362
Raw materials 44,296 183,722
Inventory Reserve (367,833 ) (396,372 )
   
 
 
Inventories, net $ 3,880,399 $ 2,113,712
   
 
 

9. Property and Equipment

Property and equipment are carried at cost. Depreciation is provided for in amounts sufficient to relate the cost of depreciable assets to the Entity over their estimated service lives using the straight-line method over a period ranging from 3 to 10 years for equipment, 5 to 10 years for furniture and fixtures, 3 years for software, and over the shorter of the estimated service life or the lease term for leasehold improvements.

10. Intangible Assets

The Entity has identifiable intangible assets at December 31, 2003 and 2002 totaling $78,651,624 and $60,242,856, respectively. These assets represent product licenses and distribution rights and were created through the Parent’s acquisition of SkyePharma’s Solaraze® Gel skin treatment in 2001 and certain of the assets of Bioglan Pharma Inc. from Bioglan Plc in 2002. Further, when the Parent completed the transaction with Pharma Services, the Parent allocated the purchase price to the assets acquired and liabilities assumed based upon their respective fair values as determined by an independent third-party valuation firm as of the date of the acquisition. This allocation included the identifiable intangible assets of Bioglan. As a result, the identifiable intangible assets of Bioglan were increased by a net amount of $11,308,794. The Entity amortizes the intangible assets over the lives, ranging from 9-12 years, of these products. Further, the Parent allocated $530,458 of the goodwill resulting from the Pharma Services transaction (see Note A.2) to the Entity based upon the relative fair value of the Entity’s assets to the assets of the Parent’s reporting unit.

The Entity assesses the value of identifiable intangibles whenever events or changes in circumstances indicate that the carrying value may not be recoverable, and that there may have been an other than temporary decline in value. Some factors the Entity considers important which could trigger an impairment review include the following: (i) significant underperformance relative to expected historical or projected future operating results; (ii) significant changes in the manner of use of the acquired assets or the strategy for the Entity’s overall business; and (iii) significant negative industry or economic trends.

If the Entity were to determine that the carrying value of intangible assets may not be recoverable based upon the existence of one or more of the above indicators of impairment, the Entity would first perform an assessment of the asset’s recoverability based on expected undiscounted future net cash flow, and if the resulting amount is less than the asset’s value, the Entity would measure any other than temporary decline in value based on a projected discounted cash flow method using a discount rate determined by the Entity’s management to be commensurate with the risk inherent in the Entity’s current business model.

 
  10 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

11. Accrued Expenses

Supplemental information on the accrued expenses at December 31, 2003 and 2002 are as follows:

    2003
Successor

2002
Predecessor

Employee compensation $1,367,407 $   792,003  
Royalties 1,263,506 3,765,662  
Professional services 701,325 462,113  
Other 204,075 275,982  
   
 
 
Accrued expenses $3,536,313 $5,295,760  
   
 
 

12. Revenue Recognition

     The Entity recognizes product sales when title passes to the customer upon their receipt of goods consistent with Securities Exchange Commission Staff Accounting Bulletin No. 104, “Revenue Recognition in Financial Statements.” Accordingly, revenue is recognized when all four of the following criteria are met: (i) persuasive evidence that an arrangement exists; (ii) delivery of the products has occurred; (iii) the selling price is both fixed and determinable; and (iv) collectibility is reasonably probable. The Entity’s customers consist primarily of large pharmaceutical wholesalers who sell directly into the retail channel. Sales are net of allowances for estimated returns, rebates and discounts. The Entity is obligated to accept from customers the return of products that are nearing or have reached their expiration date. The Entity also monitors product ordering patterns, actual returns and analyzes wholesale inventory levels to estimate potential product return rates. When the Entity lacks a sufficient historical basis to estimate return rates, the Entity recognizes net sales and the related cost of sales when it receives end-user prescription data from third-party providers. Although the Entity believes the product return allowances are adequate, if actual product returns exceed the Entity’s estimates, then results of operations could be adversely affected. These revenue reductions are reflected as a reduction to accounts receivable through an allowance.

     The Entity does not provide price protection to wholesale customers and the Entity typically permits product returns only if the product is damaged or if it is returned within six months prior to expiration and 12 months after expiration.

13. Risks, Uncertainties and Certain Concentrations

     The Entity’s future financial results involve a number of risks and uncertainties. Factors that could affect the Entity’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, maintaining Adoxa® and Solaraze® Gel sales levels, dependence on key personnel, government regulation, manufacturing disruptions, competition, reliance on certain customers and vendors, absence of redundant facilities, and credit risk.

     The Entity is potentially subject to concentrations of credit risk, which consist principally of cash and cash equivalents, and trade accounts receivable. The cash and cash equivalent balances at December 31, 2003 and 2002 were principally held by one institution and are in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limit. As of December 31, 2003 and 2002, two wholesale customers accounted for $4,128,960 and $3,823,426 or 85% and 82%, respectively, of the gross accounts receivable balance.

     The Entity maintains $30,000,000 of product liability insurance on its products. This insurance is in addition to required product liability insurance maintained by the manufacturers of the Entity’s products. The Entity believes that this amount of insurance coverage is adequate and reasonable, although the Entity cannot assure that product liability claims will not exceed that coverage. In addition, the Entity may not be able to maintain its liability insurance at reasonable premium rates, if at all. To date no product liability claim has been made against the Entity and the Entity is not aware of any pending or threatened claim.

 
  11 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

All manufacturers, marketers, and distributors of human pharmaceutical products are subject to regulation by the United States Food and Drug Administration (“FDA”). New drugs are typically subject to an FDA-approved new drug application before being marketed in the United States. Some prescription and other drugs are not the subject of an approved marketing application but, rather, are marketed subject to the FDA’s regulatory discretion and/or enforcement policies. Any change in the FDA’s enforcement discretion and/or policies could alter the way the Entity conducts business and any such change could severely impact the Entity’s future profitability.

The Adoxa® and Solaraze® Gel product line accounted for approximately 89%, 89% and 73% of net sales for the periods from September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, respectively. Changes in the performance of the Entity’s Adoxa® and Solaraze® Gel product line, in particular, will have a material effect on the future of the Entity, including the risk of competing products being introduced into the market.

For the periods January 1, 2003 through September 25, 2003 and September 26, 2003 through December 31, 2003, two vendors that manufacture and package products for the Entity individually accounted for approximately 58%, and 31%, and 54% and 35%, respectively, of the Entity’s cost of goods sold. For the period from March 22, 2002 through December 31, 2002, the same two vendors individually accounted for approximately 46% and 34%, respectively, of the Entity’s cost of goods sold. No other vendor, packager or manufacturer accounted for more than 10% of the Entity’s cost of goods sold for the periods presented. The Entity currently has no manufacturing facilities of its own and, accordingly, is dependent upon maintaining its existing relationship with its vendors to avoid a disruption in the supply of products. There can be no assurance that the Entity would be able to replace its current vendors without any disruption to the Entity.

14. Income Taxes

Federal and state income taxes have been computed in the accompanying financial statements as if the Entity were a stand alone taxpayer.

All taxes are paid by the parent company and/or affiliate companies.

15. Advertising and Promotion

The Entity expenses advertising and promotion costs as incurred. Total advertising and promotion costs charged to expense amounted to approximately $1,395,062, $4,191,556 and $2,747,061 for the periods from September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, respectively.

16. Shipping and Handling Costs

The Entity expenses shipping and handling costs as incurred. Shipping and handling costs charged to cost of sales amounted to $49,936, $162,533 and $109,554 for the periods from September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, respectively.

17. Stock Based Compensation

The Entity has historically participated in the Parent’s stock option plans to provide incentive compensation to eligible employees, officers and directors in the form of incentive stock options, non-qualified stock options, stock appreciation rights and restricted stock. These plans provided certain employees with options to purchase shares of common stock of the Parent. The Parent’s Board of Directors determined the option price (not to be less than fair market value for incentive options) at the date of grant. Options, particularly those assumed or exchanged as a result of acquisitions, had various vesting schedules and

 
  12 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

terms. The majority of options granted under the Parent’s stock option plans typically vested 25% per year over four years and expired 10 years from the date of grant. The plan was suspended during 2003 and later terminated due to Pharma Services acquiring all of the issued and outstanding shares of the Parent’s common stock.

The Entity has elected to follow Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB 25”) and related interpretations in accounting for its employee stock options because the alternative fair value accounting provided for under SFAS No. 123, “Accounting for Stock-Based Compensation”, as amended by SFAS No. 148, requires use of option valuation models that were not developed for use in valuing employee stock options. Under APB 25, because the exercise price of the employee stock options equals or exceeds the market price of the underlying stock on the date of grant, no compensation expense is recognized.

Pharma Services issued options to purchase 12,500 shares of its common stock to certain of the Entity’s employees during the fourth quarter of 2003. As of December 31, 2003, there are options to acquire 12,500 shares of Pharma Services outstanding. There were no outstanding stock options to acquire the Parent’s common stock as of December 31, 2003.

Pro forma information regarding net income is required by SFAS No. 123, as amended by SFAS No. 148, and has been determined as if the Entity had accounted for the stock options granted by its Parent company and Pharma Services, to the Company’s employees under the fair value method of SFAS No. 123. The per share weighted-average fair value of stock options granted during the period from September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002 was $0.0025, $4.16 and $3.81, respectively, per share on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions:

    September 26, 2003
through
December 31, 2003

Expected dividend yield 0%
Risk-free interest rate 3.1%
Expected volatility 65.0%
Expected life (in years from end of vesting term) 1.70

The Black-Scholes option pricing model was developed for use in estimating the fair value of trade options that have no vesting restrictions and are freely transferable. All available option pricing models require the input of highly subjective assumptions including the expected stock price volatility. Because the stock options of Pharma Services granted to the Entity’s employees have characteristics significantly different from those of traded options and changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not provide a reliable single measure of the fair value of the stock options.

 
  13 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

The Entity’s portion of the Parent’s stock option activity during the periods indicated is as follows:

  Number of
Options

Weighted
Average
Exercise Price

Outstanding at March 22, 2002 $     —  
     Granted 110,021 14.86  
     Exercised  
     Canceled  
 
 
 
Outstanding at December 31, 2002 110,021 14.86  
     Granted 49,759 13.59  
     Exercised (738 ) 9.76  
     Canceled (159,042 ) 14.48  
 
 
 
Outstanding at September 25, 2003 $    —  
 
 
 

The Entity’s portion of the Pharma Services’ stock option activity during the periods from September 26, 2003 through December 31, 2003 is as follows:

  Number of
Options

Weighted
Average
Exercise Price

     Granted 12,500   $14.50  
     Exercised    
     Canceled    
 
 
 
Outstanding at December 31, 2003 12,500   $14.50  
 
 
 

None of the above Pharma Services options are exercisable at December 31, 2003 and the weighted average remaining life of these options is 9.84 years.

  September 26,
2003 through
December 31,
2003

January 1, 2003
through
September 25,
2003

March 22, 2002
through
December 31,
2002

Net income as reported $7,357,419 $4,418,924 $139,891
Less: pro forma adjustment for stock based
         compensation, net of income tax 81,203 119,053
 
 
 
 
Pro forma net income $7,357,419 $4,337,721 $  20,838
 
 
 
 

NOTE B – INTANGIBLE ASSETS

Details of intangible assets are summarized as follows:

    December 31, 2003
  December 31, 2002
    Cost
  Accumulated
Amortization

  Net
  Cost
  Accumulated
Amortization

  Net
        Successor           Predecessor    
                         
Licenses $81,224,976 $2,573,352 $78,651,624 $62,884,333 $2,641,477 $60,242,856

 
  14 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

Licenses are intangible assets with definite useful lives and therefore continue to be amortized under SFAS 142.

The following relates to the Entity’s intangible assets with definitive useful lives:

Amortization Expense

For the period from March 22, 2002 through December 31 2002 $2,335,574
For the period from January 1, 2003 through September 25, 2003 4,183,957
For the period from September 26, 2003 through December 31, 2003 2,483,339

Estimated Amortization Expense

Year ending December 31, 2004 $  7,393,562
Year ending December 31, 2005 9,461,700
Year ending December 31, 2006 10,036,810
Year ending December 31, 2007 11,175,730
Year ending December 31, 2008 11,326,414

Estimated amortization expense can be affected by various factors including future acquisitions or divestitures of product and/or licensing and distribution rights.

Intangible assets arose principally from the following significant transactions:

In December 2001, the Parent acquired the license to market SkyePharma’s Solaraze® Gel skin treatment in the United States, Canada and Mexico for 14 years from Bioglan Pharma Plc for a total consideration of $26.7 million. The Entity has a commitment to pay royalties to SkyePharma based on a percentage of net sales of Solaraze® Gel. Pursuant to the license, the Entity may pursue additional indications for the compound, which will be facilitated through the Entity’s ownership rights in the Solaraze® Gel New Drug Application and Investigational New Drug Application.

Effective March 22, 2002, the Parent acquired certain assets of Bioglan Pharma, Inc. for a total consideration of approximately $27.9 million. Under the purchase method of accounting, the results of operations of Bioglan Pharma, Inc. are included in the Entity’s results of operations as of March 22, 2002 and the assets and liabilities of Bioglan Pharma, Inc. were recorded at their respective fair values. The assets included distribution rights to market Adoxa® in the United States for nine years along with other products and product rights that Bioglan Pharma, Inc. had previously marketed, as well as approximately $1.6 million in cash. This acquisition resulted in total intangible assets of $29.3 million. Under certain of the contracts acquired, the Entity has commitments to pay royalties based on a percentage of net sales of the acquired product rights.

NOTE C – PROPERTY AND EQUIPMENT

Property and equipment are summarized as follows:

    December 31, 2003
Successor

December 31, 2002
Predecessor

Furniture and Fixtures $ 213,348 $ 252,937
Equipment 303,252 181,755
Software 386,750 238,485
Leasehold Improvements 81,194 35,189
   
 
 
984,544 708,366
Accumulated Depreciation (104,905 ) (174,746 )
   
 
 
$ 879,639 $ 533,620
   
 
 

Assets under capital lease were $65,125 as of December 31, 2003. Related accumulated depreciation was $6,499 as of December 31, 2003. No capital leases existed before 2003.

 
  15 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

NOTE D – INCOME TAXES

Federal and state income taxes have been computed in the accompanying financial statements as if the Entity were a stand alone taxpayer.

All taxes are paid by the parent company and/or affiliate companies and, accordingly, all tax liabilities related to the Entity are included in the due to affiliates balance.

The provision for income tax expense is as follows:

  September 26, 2003
through
December 31, 2003

Successor
January 1, 2003
through
September 25, 2003

Predecessor
March 22, 2002
through
December 31, 2002

Predecessor
Current            
   Federal $ (22,478 ) $ 700,563   $ 1,121,293  
   State 30,150   97,565   119,193  
   Foreign 566,611   511,812   (28,194 )
 
 
 
 
  574,283   1,309,940   1,212,292  
 
 
 
 
Deferred            
   Federal 258,502   (475,650 ) (878,150 )
   Foreign 25,850   (47,565 ) (87,815 )
 
 
 
 
284,352   (523,215 ) (965,965 )
 
 
 
 
  $ 858,635   $ 786,725   $  246,327  
 
 
 
 

The difference between the actual Federal income tax expense and the amount computed by applying the prevailing statutory rate to income before income taxes is reconciled as follows:

  September 26, 2003
through
December 31, 2003
Successor

January 1, 2003
through
September 25, 2003
Predecessor

March 22, 2002
through
December 31, 2002
Predecessor

Tax at statutory rate 35.0 % 35.0 % 35.0 %
State income tax expense, net of Federal
      tax effect
0.3   0.5   6.5  
Foreign earnings taxed at different rates (24.8 ) (20.4 ) 22.3  
 Other (0.0 ) (0.0 ) (0.0 )
Total 10.5 % 15.1 % 63.8 %

NOTE E – RELATED PARTY TRANSACTIONS

As discussed in Note A, the Parent performed certain services and incurred certain costs for the Entity. Services provided include business development, marketing, finance, and human resources. The costs of the services provided by the Parent have been allocated to the Entity based on the net sales or headcount of the Entity relative to the total net revenues or headcount of the Parent.

Costs allocated to the Entity for these services were $124,456, $349,297 and $285,303 for the periods from September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, respectively, and have been reflected in the accompanying statements of operations in management fee and cost share fees.

 
  16 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

NOTE F – COMMITMENTS AND CONTINGENCIES

1. Leases

The Entity leases certain office space, vehicles and equipment under capital and operating leases. The leases expire at various dates through December 31, 2008. Rental expenses under these agreements were approximately $199,115, $515,326 and $561,912 for the periods from September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, respectively.

The following is a summary of future minimum payments under capitalized leases and under operating leases that have initial or remaining non-cancelable lease terms in excess of one year at December 31, 2003.

    Operating Leases
Capital Leases
2004 $    961,955 $ 19,939
2005 677,825 19,939
2006 429,091 12,543
2007 7,260
2008 5,444
Thereafter 0
   
 
 
Total minimum lease payments $ 2,068,871 65,125
   
     
Amounts representing interest     (7,240 )
       
 
Total principal payments     $57,885
       
 

2. Distribution Arrangement

The Entity has a distribution arrangement with a third party public warehouse located in Tennessee to warehouse and distribute substantially all of its products. This arrangement provides that the Entity will be billed based on invoiced sales of the products distributed by such party, plus certain additional charges.

3. Legal Proceedings

Specific Litigation

The Entity is involved in the following specific litigation: (1) Biogen, Inc. filed before the Trademark Trial and Appeal Board an opposition to Bioglan Pharmaceuticals Company’s pending BIOGLAN PHARMACEUTICALS & Design trademark application, Serial No. 78/136,606, on September 25, 2003, Opposition No. 91157995, and to Bioglan’s pending BIOGLAN PHARMA INC. & Design trademark application, Serial No. 76/099,139, on September 23, 2003, Opposition No. 91158015. Counsel for Bioglan are in discussions in an attempt to resolve this matter; (2) A former employee of Bioglan, filed suit on February 5, 2004 in the Superior Court of the County of Los Angeles for wrongful termination based on alleged race discrimination. The employee was terminated in November 2002 for performance reasons. His claim asks for pay, damages and attorney fees. Settlement discussions are currently taking place and the employee has been offered to settle for five months salary. Bioglan is proceeding with discovery at this time; and (3) Bioglan also has received a demand letter from a former employee, claiming gender discrimination. The employee was terminated in February 2004 for performance reasons. The employee was offered to accept one month’s salary as severance in exchange for a signed release in favor of Bioglan. No claim has been filed.

While the Entity’s management currently believes that the ultimate outcome of these proceedings, individually and in the aggregate, will not have a material adverse effect on the Entity’s financial statements, litigation is subject to inherent uncertainties. Were an unfavorable ruling to occur, there exists the possibility of a material adverse impact on the results of operations for the period in which the ruling occurs.

 
  17 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

General Litigation

The Entity is party to other routine actions and proceedings incidental to its business. There can be no assurance that an adverse determination on any such action or proceeding would not have a material adverse effect on the Entity’s business, financial condition or results of operations.

The Entity accounts for legal fees as their services are incurred.

4. Defined Contribution 401(k) Plan

Bioglan participates in the Parent’s defined contribution 401(k) plan whereby the Entity matches employee contributions at varying percentages, set at the discretion of the Board of Directors. For the periods from September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, the Entity expensed $28,837, $104,679 and $54,648, respectively, for the matching contributions.

5. Contract Manufacturing Agreements

The Entity has supply and distribution agreements for each of its key products. These suppliers include but are not limited to Patheon Inc., Par Pharmaceuticals, Cardinal Health and DPT Laboratories. These supply and distribution agreements may vary in terms and commitments but may be terminated if the other party commits a material breach of its obligations. There are no minimum purchase requirements. Each supplier delivers product based on a 12 month rolling forecast supplied by the Entity. Product manufacturing pricing typically increases or decreases yearly based on volume and/or Consumer Price Index fluctuations.

6. Guarantee of Parent Debt

In connection with the Pharma Services transaction (see Note A.2), the Parent issued $450,000,000 of 10% Senior Subordinated Notes due 2013. The Parent and all of its wholly owned domestic subsidiaries (“Guarantors”) have fully and unconditionally guaranteed, on a joint and several basis, the Company’s obligations under the related indentures (the “Guarantees”). Each Guarantee is subordinated in right of payment to the Guarantors’ existing and future senior debt, including obligations under the senior secured credit facility. Bioglan Pharmaceuticals Company is one of the Guarantors under this debt agreement.

NOTE G – SUBSEQUENT EVENT

On June 9, 2004, the Parent entered into an agreement with Bradley Pharmaceuticals (“Bradley”) to sell the assets of the Entity. Under the agreement, Bradley will acquire the Entity’s interests in the dermatology products on the market in the United States, including Solaraze® (diclofenac sodium) Gel, ADOXA® (doxycycline), Zonalon® (doxepin hydrochloride), and Tx Systems® for a purchase price of approximately $183 million in cash, plus direct costs for transferred inventory.

 
  18 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

NOTE H – QUARTERLY FINANCIAL DATA (Unaudited)

The following is a summary of unaudited quarterly results of operations:

    2003
    First Quarter
Second Quarter
July 1, 2003 through September 25, 2003
September 26, 2003 through September 30, 2003
Fourth Quarter
    Predecessor Predecessor Predecessor Successor Successor
           
Net sales $ 13,711,926 $ 14,838,255 $ 5,342,063 $ 279,795 $ 18,621,700
             
Income (loss) from operations 3,966,627 3,800,761 (2,561,075) (67,407) 5,136,002
             
Income (loss) before income tax expense 4,072,813 4,172,638 (3,039,802) 158,165 8,057,889
             
NET INCOME (LOSS) $ 3,457,292 $ 3,542,031 $ (2,580,399) $ 141,635 $ 7,215,784
   




       
      2002
      March 22, 2002 through
March 31, 2002

Second Quarter
  Third Quarter
Fourth Quarter
      Predecessor Predecessor Predecessor Predecessor
           
Net sales   $ 338,873 $ 3,526,125 $ 6,321,925 $ 12,082,284
             
(Loss) income from operations   (80,526) (2,229,765) (338,333) 3,057,783
             
(Loss) income before income tax expense   (80,087) (2,225,262) (338,095) 3,029,662
             
NET (LOSS) INCOME   $ (29,008) $ (806,004) $ (122,461) $ 1,097,364
   



 

  19 

 


  EX-99.3 4 e19367ex99_3.htm FINANCIAL STATEMENTS

EXHIBIT 99.3

Bioglan Pharmaceutical
Operations of
Quintiles Transnational Corp.
Financial Statements

 
   

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

CONTENTS

Page(s)

Reports of Independent Auditors   1- 2
     
Financial Statements    
     
Balance Sheets   3
     
Statements of Operations   4
     
Statements of Entity Equity   5
     
Statements of Cash Flows   6
     
Notes to Financial Statements   7 - 20

   

 


 

[LETTERHEAD OF PRICEWATERHOUSECOOPERS LLP]

Report of Independent Auditors

To the Board of Directors and Shareholders of Quintiles Transnational Corp.:

In our opinion, the accompanying balance sheets and the related statements of operations, of entity equity and of cash flows present fairly, in all material respects, the financial position of the Bioglan Pharmaceutical Operations (the “Entity”) of Quintiles Transnational Corp. (“Quintiles”) at August 10, 2004 and December 31, 2003 and the results of its operations and its cash flows for the periods from January 1, 2004 through August 10, 2004 and September 26, 2003 through December 31, 2003 in conformity with accounting principles generally accepted in the United States of America. These financial statements are the responsibility of the Entity’s management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

The Entity was part of Quintiles and consequently, as discussed in Notes A.1 and A.2, these financial statements have been derived from the accounting records of Quintiles and reflect certain assumptions and allocations. Moreover, as discussed in Note A.2, the Entity relied on Quintiles for certain administrative, management and other services. Accordingly, these financial statements do not necessarily reflect the financial position, results of operations and cash flows of the Entity had it been a separate stand-alone entity.

/s/ PricewaterhouseCoopers LLP

September 21, 2004

 
  1 

 


 

[LETTERHEAD OF PRICEWATERHOUSECOOPERS LLP]

Report of Independent Auditors

To the Board of Directors and Shareholders of Quintiles Transnational Corp.:

In our opinion, the accompanying statements of operations, of entity equity and of cash flows present fairly, in all material respects, the results of the operations and cash flows of the Bioglan Pharmaceutical Operations (the “Entity”) of Quintiles Transnational Corp. (“Quintiles”) for the periods from January 1, 2003 through September 25, 2003, and March 22, 2002 through December 31, 2002 in conformity with accounting principles generally accepted in the United States of America. These financial statements are the responsibility of the Entity’s management; our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

The Entity was part of Quintiles and consequently, as discussed in Notes A.1 and A.2, these financial statements have been derived from the accounting records of Quintiles and reflect certain assumptions and allocations. Moreover, as discussed in Note A.2, the Entity relied on Quintiles for certain administrative, management and other services. Accordingly, these financial statements do not necessarily reflect the results of operations and cash flows of the Entity had it been a separate stand-alone entity.

/s/ PricewaterhouseCoopers LLP

July 16, 2004

 
  2 

 


 

Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

BALANCE SHEETS

 

 

 

August 10,
2004

December 31,
2003

 

Successor Successor

ASSETS

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

Cash and cash equivalents

$      466,612    $  1,540,721   

 

Accounts receivable - net of allowances

1,555,052   4,469,781  

 

Prepaid and other assets

384,707   566,570  

 

Inventories

6,052,877   3,880,399  
     
 
 

 

 

Total current assets

8,459,248   10,457,471  

Property and equipment, net

642,614   879,639  

Goodwill

530,458   530,458  

Intangible assets, net

72,792,595   78,651,624  

Other assets

5,477   5,604  
     
 
 

 

 

Total Assets

$ 82,430,392    $ 90,524,796   

 

 

 


 
 

LIABILITIES AND ENTITY EQUITY

       

CURRENT LIABILITIES

       

 

Accounts payable

$      667,414    $ 1,413,435   

 

Accrued expenses

3,922,955   5,536,313  

 

Capital lease obligations, current portion

16,667   16,667  
     
 
 

 

 

Total current liabilities

4,607,036   6,966,415  

LONG-TERM LIABILITIES

       

Capital lease obligations, less current portion

31,166   41,218  

Due to affiliates

12,226,573    22,767,167  

COMMITMENTS AND CONTINGENCIES

       

ENTITY EQUITY

       

 

Contributed capital

49,685,601   49,685,601  

 

Accumulated other comprehensive income

2,160,384   3,706,976  

 

Retained earnings

13,719,632   7,357,419  
     
 
 

 

 

 

65,565,617   60,749,996  
   
 
 

 

Total Liabilities and Entity Equity

$ 82,430,392    $ 90,524,796   
   
 
 

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

 
  3 

 


 

Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

STATEMENTS OF OPERATIONS

  January 1, 2004
through
August 10,
2004

September 26,
2003 through
December 31,
2003

January 1, 2003
through
September 25,
2003

March 22, 2002
through
December 31,
2002

  Successor Successor   Predecessor   Predecessor
Net sales $38,217,843    $18,901,495   $33,892,244   $22,269,207  
                 
Cost of sales, exclusive of depreciation and
    amortization
9,515,823   4,768,935   8,157,837   6,176,417  
Selling, general and administrative expenses 14,747,633   6,355,473   15,786,603   12,857,738  
Management fee and cost share fee 303,656   124,456   349,297   285,303  
Depreciation and amortization 4,318,409   2,584,036   4,392,194   2,540,590  
 
 
 
 
 
      Total cost of sales and operating expenses 28,885,521   13,832,900   28,685,931   21,860,048  
 
 
 
 
 
      Income from operations 9,332,322   5,068,595   5,206,313   409,159  
 
 
 
 
 
Interest expense (income), net 277,353   118,150   63,494   (5,255 )
Foreign currency loss (gain) 1,204,862   (3,265,609 ) (62,830 28,196  
 
 
 
 
 
      Other expense (income), net 1,482,215   (3,147,459 ) 664   22,941  
 
 
 
 
 
      Income before income tax expense 7,850,107   8,216,054   5,205,649   386,218  
Income tax expense 1,487,894   858,635   786,725   246,327  
 
 
 
 
 
      NET INCOME $ 6,362,213   $7,357,419   $ 4,418,924   $ 139,891  
 
 
 
 
 

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

 
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Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

STATEMENTS OF ENTITY EQUITY

    Contributed
Capital

Retained
Earnings

Comprehensive
Income

Accumulated
Other
Comprehensive
Income

Total
Predecessor:
Balance at March 22, 2002
  $                 —   $                   —       $                    —     $                    —
Capital contribution   28,316,485         28,316,485
 Net income     139,891   $          139,891     139,891
Foreign currency adjustment       1,065,304   1,065,304   1,065,304
           
         
Comprehensive income from March 22, 2002
through December 31, 2002
        $      1,205,195    
   
 
 
 
 
 
Balance at December 31, 2002   28,316,485   139,891     1,065,304     29,521,680
Capital contribution   154,470         154,470
Net income     4,418,924   $      4, 418,924     4, 418,924
Foreign currency adjustment       3,751,275   3,751,275   3,751,275
           
         
Comprehensive income from January 1, 2003
through September 25, 2003
      $      8,170,199    
   
 
 
 
 
 
Balance at September 25, 2003   $28,470,955   $    4,558,815       $     4,816,579   $ 37,846,349
   
 
     
 
 
Successor:                    
Balance at September 26, 2003   $                 —   $                  —       $               —   $                —
Capital contribution   49,685,601         49,685,601
Net income     7,357,419   $      7,357,419     7,357,419
Foreign currency adjustment       3,706,976   3,706,976   3,706,976
           
         
Comprehensive income from September 26, 2003
through December 31, 2003
      $   11,064,395    
   
 
 
 
 
 
Balance at December 31, 2003   49,685,601   7,357,419       3,706,976   60,749,996
Net income     6,362,213   $      6,362,213     6,362,213
Foreign currency adjustment       (1,546,592 )   (1,546,592 ) (1,546,592 )
           
         
Comprehensive income from January 1, 2004 through August 10, 2004       $   15,880,016    
   
 
 
 
 
 

Balance at August 10, 2004

 

$49,685,601

 

$ 13,719,632

 

 

 

$   2,160,384

 

$    65,565,617

   
 
     
 
 

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

 
  5 

 


 

Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

STATEMENTS OF CASH FLOWS

      January 1,
2004 through
August 10,
2004

  September 26,
2003 through
December 31,
2003

January 1, 2003
through
September 25,
2003

  March 22, 2002
through
December 31,
2002

  Successor   Successor Predecessor   Predecessor
Cash flows from operating activities:            
    Net income $    6,362,213     $    7,357,419   $   4,418,924     $      139,891  
  Adjustments to reconcile net income to net cash provided by operating activities          
    Depreciation 236,093     100,697   208,237     205,016  
    Amortization 4,082,316     2,483,339   4,183,957     2,335,574  
    Loss on disposal 21,832     —       —     —  
    Allowance for doubtful accounts —     —   24,175     50,745  
    Changes in operating assets and liabilities:            
      Accounts receivable 2,914,729     (2,401,092) 2,365,439     154,216  
      Inventories (2,172,478)   1,966,555   (3,733,242)   (157,991)
    Prepaid expenses and other assets 181,991     (145,470) 114,653     (184,752)
    Accounts payable (746,021)   1,000,930   (936,712)   580,845  
    Accrued expenses and other payables (1,613,359)   1,760,881   (2,976,960)   602,375  
 
 

 
Net cash provided by operating activities 9,267,316     12,123,259   3,668,471     3,725,919  
             
Cash flows from investing activities:            
  Purchase of property and equipment (20,900)   (76,334) (513,494)   (218,115)
  Acquisition of trademarks, licenses, etc.   —     (28,525,725)
 
 

 
Net cash (used in) investing activities (20,900)   (76,334) (513,494)   (28,743,840)
             
Cash flows from financing activities:            
  Receipt of capital contributions   —   154,470     28,316,484  
  Payments to affiliate (10,294,169)   (10,856,463) (3,024,294)   (3,270,036)
  Repayments of capital lease obligations (10,052)   (6,395) (845)   —  
 
 

 
Net cash (used in) provided by financing
    activities
(10,304,221)   (10,862,858) (2,870,669)   25,046,448  
               
  Effect of foreign currency exchange rate changes on cash (16,304)   20,988   22,235     596  
  (DECREASE) INCREASE IN CASH AND CASH  EQUIVALENTS (1,074,109)   1,205,055   306,543     29,123  
Cash and cash equivalents at beginning of
     period
1,540,721     335,666   29,123     —  
 
 

 
Cash and cash equivalents at end of period $     466,612     $   1,540,721   $ 335,666     $     29,123  
 
 

 
Supplemental disclosures of cash flow information:          
  Cash paid during the period for:            
    Interest $             —     $               —   $        —     $           —  
    Income taxes $             —     $               —   $        —     $           —  
Non-cash Investing and Financing Activities:            
  Push down of goodwill and other intangibles $             —     $ 11,839,252   $        —     $           —  
  Acquisition of property and equipment under capital leases $             —     $        34,699   $ 30,426    $           —  

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

 
  6 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

NOTE A – ORGANIZATION, NATURE OF ENTITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

1. The Entity

The primary business activity of the Bioglan Pharmaceutical Operations of Quintiles Transnational Corp. is the marketing of various dermatology pharmaceutical products, which have been primarily acquired through the purchase or license of trademark rights and patents. These operations are a combination of Quintiles Transnational Corp.’s wholly-owned subsidiary, Bioglan Pharmaceuticals Company, and certain activities conducted at Quintiles Transnational Corp.’s wholly-owned subsidiaries in Ireland and Bermuda (collectively referred to as “Bioglan” or the “Entity”).

On August 10, 2004, Quintiles Transnational Corp. (the “Parent”) sold the assets of the Entity to Bradley Pharmaceuticals, Inc. (“Bradley”) for a purchase price of approximately $183 million in cash, plus direct costs for transferred inventory. Under the purchase agreement, Bradley will acquire the Entity’s interests in the dermatology products on the market in the United States, including Solaraze® (diclofenac sodium) Gel, ADOXA® (doxycycline), Zonalon® (doxepin hydrochloride), and Tx Systems®.

A summary of the significant accounting policies of the Entity applied in the preparation of the accompanying financial statements follows:

2. Basis of Presentation

The financial statements for the Entity include the accounts of Bioglan Pharmaceuticals Company and certain accounts from Quintiles Bermuda, Inc. and Bioglan Dublin, Ltd. (a foreign sales corporation). The business units in the preceding sentence are wholly-owned subsidiaries of the Parent. All inter-entity transactions have been eliminated.

The accompanying financial statements present on a historical basis the financial position, results of operations, changes in equity and cash flows for all periods presented and reflect the “carve out” of the Entity from the consolidated financial statements of Quintiles Transnational Corp.

Certain prior period amounts have been reclassified to conform with the current year presentation.

Transfers of operating funds between the Entity, the Parent and the Parent’s various business units occur primarily on a noninterest-bearing basis, with the net amount of these transfers reflected as due to affiliates in the accompanying financial statements. The net balance in due to affiliates at August 10, 2004 and December 31, 2003 of $12,226,573 and $22,767,167, respectively, is classified as a due to affiliates in the accompanying balance sheets. At August 10, 2004 and December 31, 2003, the Entity has an intercompany note payable denominated in Canadian dollars totaling C$20,000,000 (US$15,298,000 at August 10, 2004 and US$15,454,000 at December 31, 2003) with an annual interest rate of 3% and another note, which is non-interest bearing, denominated in Singapore dollars totaling S$50,446,920 (US$29,440,823 at August 10, 2004 and US$29,617,387 at December 31, 2003). These amounts are included in the due to affiliates caption in the accompanying balance sheets.

The Parent performed certain limited services and incurred certain costs for the Entity. Services provided include business development, marketing, finance, and human resources. The costs of the services provided by the Parent have been allocated to the Entity based upon the ratio of net sales of the Entity to the total of the Parent’s consolidated net revenues for certain costs and based upon the Entity’s headcount to the Parent’s consolidated headcount for others. Costs allocated to the Entity for these services are included in the management fee and cost share fee caption in the accompanying statements of operations. In the opinion of management, the method of allocating these costs is believed to be reasonable. However, expenses allocated to the Entity are not necessarily indicative of the expenses that would have been incurred on a stand alone basis nor are they indicative of costs that may be charged or incurred in the future.

 
  7 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

On September 25, 2003 the Entity’s Parent completed a merger transaction pursuant to which the Parent was acquired by a subsidiary of a newly formed holding company, Pharma Services Holding, Inc. (“Pharma Services”). Pharma Services accounted for the transaction using the purchase method of accounting and therefore allocated the purchase price to the fair values of the Parent’s assets and liabilities on the date of purchase. The purchase accounting related to the September 2003 transaction has been pushed down to the Entity’s separate financial statements. Accordingly, as of September 26, 2003, the Entity has been presented on an entirely new basis of accounting, the Entity’s operations have been identified as predecessor and successor and, where appropriate, separated with a vertical black line.

3. Use of Estimates

In preparing financial statements in conformity with accounting principles generally accepted in the United States of America, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and net sales and expenses during the reporting period. Actual results could differ from those estimates. Some of the more significant estimates for the Entity’s financial statements relate to chargebacks, rebates, discounts and returns, and the determination of useful lives of intangible assets.

4. Fair Value of Financial Instruments

The carrying value of cash equivalents, accounts receivable, accounts payable and accrued expenses at August 10, 2004 and December 31, 2003 approximate their fair value due to the short-term nature of these items.

5. Cash and Cash Equivalents

The Entity considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash is comprised of funds held in accounts at commercial banks.

6. Accounts Receivable and Significant Customers

The Entity extends credit on an uncollateralized basis primarily to wholesale drug distributors. Historically, the Entity has not experienced significant credit losses related to its customer accounts. The Entity’s two largest customers accounted for an aggregate of approximately 79% and 85% of accounts receivable at August 10, 2004 and December 31, 2003, respectively. On August 10, 2004, Customer A owed approximately $760,341 to the Entity or 41% of accounts receivable and Customer B owed approximately $693,228 to the Entity or 38% of accounts receivable. On December 31, 2003, Customer A owed approximately $2,717,450 to the Entity or 56% of accounts receivable and Customer B owed approximately $1,411,510 to the Entity or 29% of accounts receivable. The following table presents a summary of sales to significant customers as a percentage of the Entity’s net sales:

Customer


January 1, 2004
through
August 10, 2004

Successor
September 26, 2003
through
December 31, 2003

Successor
January 1, 2003
through
September 25, 2003

Predecessor
March 22, 2002
through
December 31, 2002

Predecessor
A 50% 36% 48% 35%
B 23% 46% 29% 31%
C 16% 5% 17% 18%

 
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Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

Supplemental information on the accounts receivable balances at August 10, 2004 and December 31, 2003 are as follows:

  August 10, 2004  
December 31, 2003
Trade accounts receivable $ 1,844,462   $ 4,873,404  
 
 
 
Less allowances:        
Chargebacks/Rebates 182,571   232,431  
Discounts 32,564   96,272  
Doubtful accounts 74,275   74,920  
 
 
 
  289,410   403,623  
 
 
 
Accounts receivable, net of allowances $ 1,555,052   $4,469,781  
 
 
 

Trade receivables consist of amounts receivable for sales of product primarily to wholesale customers.

7. Allowances for chargebacks, rebates, discounts and doubtful accounts

Chargebacks are based on the difference between the prices at which the Entity sells its products to wholesalers and the sales price ultimately paid by the end-user (often governmental agencies and managed care buying groups) pursuant to fixed price contracts. The Entity records an estimate of the amount to be charged back to the Entity at the time of sale to the wholesaler. Management estimates its allowances for chargebacks, based upon factors including current contract prices, historical chargeback rates and actual chargebacks claimed. The amount of actual chargebacks claimed may differ from the amounts accrued by the Entity.

The Entity establishes and maintains rebate allowances for amounts payable to managed care organizations and state Medicaid programs for the reimbursement of a portion of the retail price of prescriptions filled that are covered by the respective plans. The amounts estimated to be paid relating to products sold are recognized as revenue reductions on a quarterly basis based on the Entity’s best estimate of the expected prescription fill rate to these managed care patients using historical experience adjusted to reflect known changes in the factors that impact such allowances.

The Entity records an estimate of the prompt payment discount amount deducted from customer’s payments at the time of sale. Typically, the Entity offers a 2% discount based upon prompt customer payments. Management estimates its allowance for discounts, based upon historical discounts claimed. The amount of actual discounts claimed may differ from the amounts accrued by the Entity.

The Entity also maintains a provision for doubtful accounts, when the Entity believes the probability of collecting the accounts receivable is remote, based upon a specific analysis of the Entity’s accounts. The amount of actual customer defaults could differ (either higher or lower) from the amounts accrued by the Entity.

8. Inventories

The Entity purchases certain raw materials and packaging components from third-party manufacturing vendors. The Entity also utilizes third parties to manufacture and package finished goods held for sale. The Entity takes title to finished goods inventories once manufactured and warehouses such goods until final distribution and sale. Inventories are carried on the books at the lower of cost or market. The Entity provides a reserve for estimated obsolescence or unmarketable inventory, based on a specific identification method, in an amount equal to the cost of the inventory. The Entity uses the first-in-first-out method to remove costs from inventory.

 
  9 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

Supplemental information on inventory balances at August 10, 2004 and December 31, 2003 are as follows:

    August 10, 2004
December 31, 2003
                               
Finished goods $ 6,173,713 $ 4,203,936
Raw materials 103,317 44,296
Inventory Reserve (224,153 ) (367,833 )
   
 
 
Inventories, net $ 6,052,877 $ 3,880,399
   
 
 

9. Property and Equipment

Property and equipment are carried at cost. Depreciation is provided for in amounts sufficient to relate the cost of depreciable assets to the Entity over their estimated service lives using the straight-line method over a period ranging from 3 to 10 years for equipment, 5 to 10 years for furniture and fixtures, 3 years for software, and over the shorter of the estimated service life or the lease term for leasehold improvements.

10. Intangible Assets

The Entity has identifiable intangible assets at August 10, 2004 and December 31, 2003 totaling $72,792,595 and $78,651,624, respectively. These assets represent product licenses and distribution rights and were created through the Parent’s acquisition of SkyePharma’s Solaraze® Gel skin treatment in 2001 and certain of the assets of Bioglan Pharma Inc. from Bioglan Plc in 2002. Further, when the Parent completed the transaction with Pharma Services, the Parent allocated the purchase price to the assets acquired and liabilities assumed based upon their respective fair values as determined by an independent third-party valuation firm as of the date of the acquisition. This allocation included the identifiable intangible assets of Bioglan. As a result, the identifiable intangible assets of Bioglan were increased by a net amount of $11,308,794. The Entity amortizes the intangible assets over the lives, ranging from 9 to 12 years, of these products. Further, the Parent allocated $530,458 of the goodwill resulting from the Pharma Services transaction (see Note A.2) to the Entity based upon the relative fair value of the Entity’s assets to the assets of the Parent’s reporting unit.

The Entity assesses the value of identifiable intangibles whenever events or changes in circumstances indicate that the carrying value may not be recoverable, and that there may have been an other than temporary decline in value. Some factors the Entity considers important which could trigger an impairment review include the following: (i) significant underperformance relative to expected historical or projected future operating results; (ii) significant changes in the manner of use of the acquired assets or the strategy for the Entity’s overall business; and (iii) significant negative industry or economic trends.

If the Entity were to determine that the carrying value of intangible assets may not be recoverable based upon the existence of one or more of the above indicators of impairment, the Entity would first perform an assessment of the asset’s recoverability based on expected undiscounted future net cash flow, and if the resulting amount is less than the asset’s value, the Entity would measure any other than temporary decline in value based on a projected discounted cash flow method using a discount rate determined by the Entity’s management to be commensurate with the risk inherent in the Entity’s current business model.

 
  10 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

11. Accrued Expenses

Supplemental information on the accrued expenses at August 10, 2004 and December 31, 2003 are as follows:

  August 10, 2004  
December 31, 2003
Accrued returns $ 2,180,579   $ 2,000,000  
Employee compensation 1,489,644   1,367,407  
Royalties 104,423   1,263,506  
Professional services 122,638   701,325  
Other 25,671   204,075  
 
 
 
Accrued expenses $ 3,922,955   $ 5,536,313  
 
 
 
12. Revenue Recognition

The Entity recognizes product sales when title passes to the customer upon their receipt of goods consistent with Securities Exchange Commission Staff Accounting Bulletin No. 104, “Revenue Recognition in Financial Statements.” Accordingly, revenue is recognized when all four of the following criteria are met: (i) persuasive evidence that an arrangement exists; (ii) delivery of the products has occurred; (iii) the selling price is both fixed and determinable; and (iv) collectibility is reasonably probable. The Entity’s customers consist primarily of large pharmaceutical wholesalers who sell directly into the retail channel. Sales are net of allowances for estimated returns, chargebacks, rebates and discounts. The Entity is obligated to accept from customers the return of products that are nearing or have reached their expiration date. The Entity’s return policy typically allows customers to return products during an eighteen-month window beginning six months prior to the expiration date of each product and up to twelve months after the expiration date. The Entity believes that it has sufficient data to estimate future returns over the return time period at the time of sale. The Entity is required to estimate the level of sales which will ultimately be returned pursuant to the Entity’s return policy and record a related allowance at the time of sale. These amounts are deducted from the Entity’s gross sales to determine net sales. The Entity’s estimates take into consideration historical returns of a given product, product specific information provided by the Entity’s customers and information obtained regarding the levels of inventory being held by the Entity’s customers, as well as overall purchasing patterns by its customers. When the Entity lacks a sufficient historical basis to estimate return rates, the Entity recognizes net sales and the related cost of sales when it receives end-user prescription data from third-party providers. Although the Entity believes the product return allowances are adequate, if actual product returns exceed the Entity’s estimates, then results of operations could be adversely affected.

The Entity does not provide price protection to wholesale customers and the Entity typically permits product returns only if the product is damaged or if it is returned within six months prior to expiration and 12 months after expiration.

13. Risks, Uncertainties and Certain Concentrations

The Entity’s future financial results involve a number of risks and uncertainties. Factors that could affect the Entity’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, maintaining Adoxa(R) and SolarazeTM Gel sales levels, dependence on key personnel, government regulation, manufacturing disruptions, competition, reliance on certain customers and vendors, absence of redundant facilities, and credit risk.

The Entity is potentially subject to concentrations of credit risk, which consist principally of cash and cash equivalents, and trade accounts receivable. The cash and cash equivalent balances at August 10, 2004 and December 31, 2003 were principally held by one institution and are in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limit. As of August 10, 2004 and December 31, 2003, two wholesale customers accounted for $1,453,569 and $4,128,960 or 79% and 85%, respectively, of the gross accounts receivable balance.

 
  11 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

The Entity maintains product liability insurance on its products. This insurance is in addition to required product liability insurance maintained by the manufacturers of the Entity’s products. The Entity believes that this amount of insurance coverage is adequate and reasonable, although the Entity cannot assure that product liability claims will not exceed that coverage. In addition, the Entity may not be able to maintain its liability insurance at reasonable premium rates, if at all. To date no product liability claim has been made against the Entity and the Entity is not aware of any pending or threatened claim.

All manufacturers, marketers, and distributors of human pharmaceutical products are subject to regulation by the United States Food and Drug Administration (“FDA”). New drugs are typically subject to an FDA-approved new drug application before being marketed in the United States. Some prescription and other drugs are not the subject of an approved marketing application but, rather, are marketed subject to the FDA’s regulatory discretion and/or enforcement policies. Any change in the FDA’s enforcement discretion and/or policies could alter the way the Entity conducts business and any such change could severely impact the Entity’s future profitability.

The Adoxa® and Solaraze® Gel product line accounted for approximately 91%, 89%, 89% and 73% of net sales for the periods from January 1, 2004 through August 10, 2004, September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, respectively. Changes in the performance of the Entity’s Adoxa® and Solaraze® Gel product line, in particular, will have a material effect on the future of the Entity, including the risk of competing products being introduced into the market.

For the period January 1, 2004 through August 10, 2004, two vendors that manufacture and package products for the Entity individually accounted for approximately 54% and 36%, respectively, of the Entity’s cost of goods sold. For the periods January 1, 2003 through September 25, 2003 and September 26, 2003 through December 31, 2003, the same two vendors that manufacture and package products for the Entity individually accounted for approximately 58% and 31%, and 54% and 35%, respectively, of the Entity’s cost of goods sold. For the period from March 22, 2002 through December 31, 2002, the same two vendors individually accounted for approximately 46% and 34%, respectively, of the Entity’s cost of goods sold. No other vendor, packager or manufacturer accounted for more than 10% of the Entity’s cost of goods sold for the periods presented. The Entity currently has no manufacturing facilities of its own and, accordingly, is dependent upon maintaining its existing relationship with its vendors to avoid a disruption in the supply of products. There can be no assurance that the Entity would be able to replace its current vendors without any disruption to the Entity.

14. Income Taxes

Federal and state income taxes have been computed in the accompanying financial statements as if the Entity were a stand alone taxpayer.

All taxes are paid by the parent company and/or affiliate companies.

15. Advertising and Promotion

The Entity expenses advertising and promotion costs as incurred. Total advertising and promotion costs charged to expense amounted to approximately $3,609,247, $1,395,062, $4,191,556 and $2,747,061 for the periods from January 1, 2004 through August 10, 2004, September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, respectively.

16. Shipping and Handling Costs

The Entity expenses shipping and handling costs as incurred. Shipping and handling costs charged to cost of sales amounted to $128,868, $49,936, $162,533 and $109,554 for the periods from January 1, 2004

 
  12 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

through August 10, 2004, September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, respectively.

17. Stock Based Compensation

The Entity has historically participated in the Parent’s stock option plans to provide incentive compensation to eligible employees, officers and directors in the form of incentive stock options, non-qualified stock options, stock appreciation rights and restricted stock. These plans provided certain employees with options to purchase shares of common stock of the Parent. The Parent’s Board of Directors determined the option price (not to be less than fair market value for incentive options) at the date of grant. Options, particularly those assumed or exchanged as a result of acquisitions, had various vesting schedules and terms. The majority of options granted under the Parent’s stock option plans typically vested 25% per year over four years and expired 10 years from the date of grant. The plan was suspended during 2003 and later terminated due to Pharma Services acquiring all of the issued and outstanding shares of the Parent’s common stock.

The Entity has elected to follow Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB 25”) and related interpretations in accounting for its employee stock options because the alternative fair value accounting provided for under SFAS No. 123, “Accounting for Stock-Based Compensation”, as amended by SFAS No. 148, requires use of option valuation models that were not developed for use in valuing employee stock options. Under APB 25, because the exercise price of the employee stock options equals or exceeds the market price of the underlying stock on the date of grant, no compensation expense is recognized.

Pharma Services issued options to purchase 12,500 shares of its common stock to certain of the Entity’s employees during the fourth quarter of 2003. As of August 10, 2004 and December 31, 2003, there are options to acquire 12,500 shares of Pharma Services outstanding. There were no outstanding stock options to acquire the Parent’s common stock as of December 31, 2003 or August 10, 2004.

Pro forma information regarding net income is required by SFAS No. 123, as amended by SFAS No. 148, and has been determined as if the Entity had accounted for the stock options granted by its Parent company and Pharma Services, to the Company’s employees under the fair value method of SFAS No. 123. There were no stock options granted during the period from January 1, 2004 through August 10, 2004. The per share weighted-average fair value of stock options granted during the periods from September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002 was $0.0025, $4.16 and $3.81, respectively, per share on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions:

  September 26, 2003
through
December 31, 2003

January 1, 2003
through
September 25, 2003

March 22, 2002
through

December 31, 2002
Expected dividend yield 0% 0% 0%
Risk-free interest rate 3.1% 2.1% 2.1%
Expected volatility 65.0% 40.0% 40.0%
Expected life (in years from end of vesting term) 1.70 0.90 0.85
       

The Black-Scholes option pricing model was developed for use in estimating the fair value of trade options that have no vesting restrictions and are freely transferable. All available option pricing models require the input of highly subjective assumptions including the expected stock price volatility. Because the stock options of Pharma Services granted to the Entity’s employees have characteristics significantly different from those of traded options and changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not provide a reliable single measure of the fair value of the stock options.

 
  13 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

The Entity’s portion of the Parent’s stock option activity during the periods indicated is as follows:

  Number of
Options

Weighted
Average
Exercise Price

Outstanding at March 22, 2002 $     —  
     Granted 110,021 14.86  
     Exercised  
     Canceled  
 
 
 
Outstanding at December 31, 2002 110,021 14.86  
     Granted 49,759 13.59  
     Exercised (738 ) 9.76  
     Canceled (159,042 ) 14.48  
 
 
 
Outstanding at September 25, 2003 $    —  
 
 
 

The Entity’s portion of the Pharma Services’ stock option activity during the periods from September 26, 2003 through August 10, 2004 is as follows:

    Number of
Options

Weighted
Average
Exercise Price

Outstanding at September 26, 2003 $     —
     Granted 12,500 14.50  
     Exercised
     Canceled
   
 
 
Outstanding at December 31, 2003 12,500 14.50  
     Granted
     Exercised
     Canceled
Outstanding at August 10, 2004 12,500 $14.50  
   
 
 

None of the above Pharma Services options are exercisable at August 10, 2004 and the weighted average remaining life of these options is 9.84 years.

 

January 1, 2004
through
August 10, 2004

September 26, 2003
through
December 31, 2003

January 1, 2003
through
September 25, 2003

March 22, 2002
through
December 31, 2002

Successor Successor Predecessor Predecessor
Net income as reported $6,362,213   $7,357,419   $4,418,924   $ 139,891  
Less: pro forma adjustment
for stock based compensation,
net of income tax
    81,203   119,053  
Pro forma net income
$6,362,213
  $7,357,419   $4,337,721   $ 20,838  


  14 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

NOTE B – INTANGIBLE ASSETS

Details of intangible assets are summarized as follows:

    August 10, 2004
  December 31, 2003
    Cost
  Accumulated
Amortization

  Net
  Cost
  Accumulated
Amortization

  Net
Licenses $79,448,263 $6,655,668 $72,792,595 $81,224,976 $2,573,352 $78,651,624
 

Licenses are intangible assets with finite useful lives and therefore continue to be amortized under SFAS 142.

The following relates to the Entity’s intangible assets with finite useful lives:

Amortization Expense

For the period from March 22, 2002 through December 31 2002 $2,335,574
For the period from January 1, 2003 through September 25, 2003 4,183,957
For the period from September 26, 2003 through December 31, 2003 2,483,339
For the period from January 1, 2004 through August 10, 2004 4,082,316

Estimated Amortization Expense

For the period from August 11, 2004 through December 31, 2004 $2,695,792
Year ending December 31, 2005 6,751,592
Year ending December 31, 2006 7,223,371
Year ending December 31, 2007 7,962,772
Year ending December 31, 2008 8,655,207

Estimated amortization expense can be affected by various factors including future acquisitions or divestitures of product and/or licensing and distribution rights.

Intangible assets arose principally from the following significant transactions:

In December 2001, the Parent acquired the license to market SkyePharma’s Solaraze® Gel skin treatment in the United States, Canada and Mexico for 14 years from Bioglan Pharma Plc for a total consideration of $26.7 million. The Entity has a commitment to pay royalties to SkyePharma based on a percentage of net sales of Solaraze® Gel. Pursuant to the license, the Entity may pursue additional indications for the compound, which will be facilitated through the Entity’s ownership rights in the Solaraze® Gel New Drug Application and Investigational New Drug Application.

Effective March 22, 2002, the Parent acquired certain assets of Bioglan Pharma, Inc. for a total consideration of approximately $27.9 million. Under the purchase method of accounting, the results of operations of Bioglan Pharma, Inc. are included in the Entity’s results of operations as of March 22, 2002 and the assets and liabilities of Bioglan Pharma, Inc. were recorded at their respective fair values. The assets included distribution rights to market Adoxa® in the United States for nine years along with other products and product rights that Bioglan Pharma, Inc. had previously marketed, as well as approximately $1.6 million in cash. This acquisition resulted in total intangible assets of $29.3 million. Under certain of the contracts acquired, the Entity has commitments to pay royalties based on a percentage of net sales of the acquired product rights.

 
  15 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

NOTE C – PROPERTY AND EQUIPMENT

Property and equipment are summarized as follows:

  August 10, 2004
December 31, 2003
Furniture and Fixtures $ 216,164 $ 213,348
Equipment 293,677 303,252
Software 386,750 386,750
Leasehold Improvements 81,194 81,194
 
 
 
977,785 984,544
Accumulated Depreciation (335,171 ) (104,905 )
 
 
 
$ 642,614 $ 879,639
 
 
 

Assets under capital lease were $62,613 and $65,125 as of August 10, 2004 and December 31, 2003, respectively. Related accumulated depreciation was $19,832, and $6,499 as of August 10, 2004 and December 31, 2003, respectively. No capital leases existed before 2003.

NOTE D – INCOME TAXES

Federal and state income taxes have been computed in the accompanying financial statements as if the Entity were a stand alone taxpayer.

All taxes are paid by the parent company and/or affiliate companies and, accordingly, all tax liabilities related to the Entity are included in the due to affiliates balance.

The provision for income tax expense is as follows:

  January 1, 2004
through
August 10, 2004
September 26, 2003
through
December 31, 2003

January 1, 2003
through
September 25, 2003

March 22, 2002
through
December 31, 2002
  Successor   Successor   Predecessor   Predecessor
                 
Current                
   Federal $    100,551   $   (22,478 $   700,563   $ 1,121,293  
   State 10,055   30,150   97,565   119,193  
   Foreign 969,214   566,611   511,812   (28,194 )
 
 
 
 
 
  1,079,820   574,283   1,309,940   1,212,292  
 
 
 
 
 
Deferred                
   Federal 370,976   258,502   (475,650 ) (878,150 )
   State 37,098   25,850   (47,565 ) (87,815 )
 
 
 
 
 
  408,074   284,352   (523,215 ) (965,965 )
 
 
 
 
 
  $ 1,487,894   $    858,635   $   786,725   $     246,327  
 
 
 
 
 


  16 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

The difference between the actual Federal income tax expense and the amount computed by applying the prevailing statutory rate to income before income taxes is reconciled as follows:

  January 1,
2004
through
August 10,
2004

Successor
September 26,
2003
through
December 31,
2003

Successor
January 1,
2003
through
September 25,
2003

Predecessor
March 22,
2002
through
December 31,
2002

Predecessor
                 
Tax at statutory rate 35.0 % 35.0 % 35.0 % 35.0 %
State income tax expense, net of
Federal tax effect
0.5 0.3 0.5 6.5
Foreign earnings taxed at different rates (16.5 ) (24.8 ) (20.4 ) 22.3
 
 
 
 
 
Total 19.0 % 10.5 % 15.1 % 63.8 %
 
 
 
 
 

NOTE E – RELATED PARTY TRANSACTIONS

As discussed in Note A, the Parent performed certain services and incurred certain costs for the Entity. Services provided include business development, marketing, finance, and human resources. The costs of the services provided by the Parent have been allocated to the Entity based on the net sales or headcount of the Entity relative to the total net revenues or headcount of the Parent.

Costs allocated to the Entity for these services were $303,656, $124,456, $349,297 and $285,303 for the periods from January 1, 2004 through August 10, 2004, September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, respectively, and have been reflected in the accompanying statements of operations in management fee and cost share fees.

 
  17 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

NOTE F – COMMITMENTS AND CONTINGENCIES

1. Leases

The Entity leases certain office space, vehicles and equipment under capital and operating leases. The leases expire at various dates through December 31, 2008. Rental expenses under these agreements were approximately $512,044, $199,115, $515,326 and $561,912 for the periods from January 1, 2004 through August 10, 2004, September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, respectively.

The following is a summary of future minimum payments under capitalized leases and under operating leases that have initial or remaining non-cancelable lease terms in excess of one year at August 10, 2004.
Operating Leases Capital Leases
  Operating Leases
Capital Leases
2004 $    219,872 $    7,703
2005 522,945 19,939
2006 321,169 12,543
2007 7,260
2008 5,445
Thereafter
 
 
 
Total minimum lease payments $ 1,063,986 52,890
 
 
 
Amounts representing interest (5,057 )
     
 
Total principal payments $   47,833
     
 

2. Distribution Arrangement

The Entity has a distribution arrangement with a third party public warehouse located in Tennessee to warehouse and distribute substantially all of its products. This arrangement provides that the Entity will be billed based on invoiced sales of the products distributed by such party, plus certain additional charges.

3. Legal Proceedings

Specific Litigation

The Entity is involved in the following specific litigation: (1) Biogen, Inc. filed before the Trademark Trial and Appeal Board an opposition to Bioglan Pharmaceuticals Company’s pending BIOGLAN PHARMACEUTICALS & Design trademark application, Serial No. 78/136,606, on September 25, 2003, Opposition No. 91157995, and to Bioglan’s pending BIOGLAN PHARMA INC. & Design trademark application, Serial No. 76/099,139, on September 23, 2003, Opposition No. 91158015. Counsel for Bioglan are in discussions in an attempt to resolve this matter; and (2) Bioglan also has received a demand letter from a former employee, claiming gender discrimination. The employee was terminated in February 2004 for performance reasons. The matter has been settled verbally for an undisclosed amount which has been accrued in the financial statements, and the Entity is waiting for signed documents.

While the Entity’s management currently believes that the ultimate outcome of these proceedings, individually and in the aggregate, will not have a material adverse effect on the Entity’s financial statements, litigation is subject to inherent uncertainties. Were an unfavorable ruling to occur, there exists the possibility of a material adverse impact on the results of operations for the period in which the ruling occurs.

General Litigation

The Entity is party to other routine actions and proceedings incidental to its business. There can be no assurance that an adverse determination on any such action or proceeding would not have a material

 
  18  

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

adverse effect on the Entity’s business, financial condition or results of operations.

The Entity accounts for legal fees as their services are incurred.

4. Defined Contribution 401(k) Plan

Bioglan participates in the Parent’s defined contribution 401(k) plan whereby the Entity matches employee contributions at varying percentages, set at the discretion of the Board of Directors. For the periods from January 1, 2004 through August 10, 2004, September 26, 2003 through December 31, 2003, January 1, 2003 through September 25, 2003 and March 22, 2002 through December 31, 2002, the Entity expensed $136,550, $28,837, $104,679 and $54,648, respectively, for the matching contributions.

5. Contract Manufacturing Agreements

The Entity has supply and distribution agreements for each of its key products. These suppliers include but are not limited to Patheon Inc., Par Pharmaceuticals, Cardinal Health and DPT Laboratories. These supply and distribution agreements may vary in terms and commitments but may be terminated if the other party commits a material breach of its obligations. There are no minimum purchase requirements. Each supplier delivers product based on a 12 month rolling forecast supplied by the Entity. Product manufacturing pricing typically increases or decreases yearly based on volume and/or Consumer Price Index fluctuations.

6. Guarantee of Parent Debt

In connection with the Pharma Services transaction (see Note A.2), the Parent issued $450,000,000 of 10% Senior Subordinated Notes due 2013. The Parent and all of its wholly owned domestic subsidiaries (“Guarantors”) have fully and unconditionally guaranteed, on a joint and several basis, the Company’s obligations under the related indentures (the “Guarantees”). Each Guarantee is subordinated in right of payment to the Guarantors’ existing and future senior debt, including obligations under the senior secured credit facility. Bioglan Pharmaceuticals Company is one of the Guarantors under this debt agreement.

 
  19 

 


 

Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS

NOTE G – QUARTERLY FINANCIAL DATA (Unaudited)

The following is a summary of unaudited quarterly results of operations:

      2004
 
    First Quarter
Second Quarter
July 1, 2004
through
August 10,
2004

 
    Successor Successor Successor  
         
Net sales $13,649,074 $22,334,087 $ 2,234,682  
           
Income (loss) from operations 2,152,366 7,977,870 (797,914
           
Income (loss) before income
tax expense
627,243 8,593,894 (1,371,030
           
NET INCOME (LOSS) $     553,764 $ 7,137,338 $ (1,328,889
 


 

    2003
    First Quarter
  Second Quarter
  July 1, 2003
through
September 25,
2003

  September 26,
2003 through
September 30,
2003

  Fourth Quarter
    Predecessor      Predecessor      Predecessor      Successor      Successor
                   
Net sales $13,711,926   $ 14,838,255   $ 5,342,063   $ 279,795   $ 18,621,700
                     
Income (loss) from operations 3,966,627   3,800,761   (2,561,075 ) (67,407 ) 5,136,002
                     
Income (loss) before income tax expense 4,072,813   4,172,638   (3,039,802 ) 158,165   8,057,889
                     
NET INCOME (LOSS) $ 3,457,292   $ 3,542,031   $ (2,580,399 ) $ 141,635   $ 7,215,784
   
 
 
 
 
         
        2002
        March 22, 2002 through
March 31, 2002

  Second Quarter
    Third Quarter
  Fourth Quarter
        Predecessor   Predecessor   Predecessor   Predecessor
                   
Net sales     $ 338,873   $ 3,526,125   $ 6,321,925   $ 12,082,284
                     
(Loss) income from operations     (80,526 ) (2,229,765 ) (338,333 ) 3,057,783
                     
(Loss) income before income tax expense     (80,087 ) (2,225,262 ) (338,095 ) 3,029,662
                     
NET (LOSS) INCOME     $ (29,008 ) $ (806,004 ) $ (122,461 ) $ 1,097,364
     
 
 
 

 
  20 

 


  EX-99.4 5 e19367ex99_4.htm NOTES TO FINANCIAL STATEMENTS

EXHIBIT 99.4

Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

BALANCE SHEETS
(Unaudited)

 
June 30, 2004
 
December 31, 2003
       
ASSETS      
CURRENT ASSETS      
     Cash and cash equivalents $        445,315   $    1,540,721
     Accounts receivable - net of allowances 8,243,192          2,469,781
     Prepaid and other assets 536,023             566,570
     Inventories 4,412,414          3,880,399
 
 
     Total current assets 13,636,944          8,457,471
       
Property and equipment, net 714,798             879,639
Goodwill 530,458        530,458
Intangible assets, net 72,432,003        78,651,624
Other assets 5,432                 5,604
 
 
     Total Assets $  87,319,635   $  88,524,796
 
 
       
LIABILITIES AND ENTITY EQUITY      
       
CURRENT LIABILITIES      
     Accounts payable $    1,142,057   $       1,413,435
     Accrued expenses 3,248,100          3,536,313
     Capital lease obligations, current portion 16,667               16,667
 
 
     Total current liabilities 4,406,824          4,966,415
       
LONG TERM LIABILITIES      
     Capital lease obligations, less current portion 33,020               41,218
     Due to affiliates 15,814,701        22,767,167
       
COMMITMENTS AND CONTINGENCIES      
ENTITY EQUITY      
     Contributed capital 49,685,601        49,685,601
     Accumulated other comprehensive income 2,330,967          3,706,976
     Retained earnings 15,048,522          7,357,419
 
 
  67,065,090        60,749,996
 
 
     Total Liabilities and Entity Equity $ 87,319,635   $  88,524,796
 
 

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


  1 


Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

STATEMENTS OF OPERATIONS
(Unaudited)

 
June 30
 
Three months ended
   
Six months ended
  2004
  2003
  2004
  2003
  Successor     Predecessor   Successor     Predecessor
Net sales $       22,334,087   $ 14,838,254   $    35,983,161   $ 28,550,180
Cost of sales, exclusive of depreciation and amortization 5,406,300        3,827,539   9,088,616         6,531,751
Selling, general and administrative expenses 6,334,736         5,263,991   12,494,027         10,457,850
Management fee and cost share fee 124,393           121,417   244,584            233,535
Depreciation and amortization 2,490,788         1,824,544   4,025,698         3,559,654
 
 
 
 
Total cost of sales and operating expenses 14,356,217       11,037,491   25,852,925         20,782,790
 
 
 
 
Income from operations 7,977,870         3,800,763   10,130,236   7,767,390
 
 
 
 
Interest expense (income), net 100,500            (35)   227,840                   (48)
Foreign currency (gain) loss (716,524)         (371,841)   681,258          (478,014)
 
 
 
 
Other (income) expense, net (616,024)        (371,876)   909,098                (478,062)
 
 
 
 
     Income before income tax expense 8,593,894            4,172,639   9,221,138         8,245,452
Income tax expense 1,456,556             630,607   1,530,035            1,246,128
 
 
 
 
NET INCOME $         7,137,338   $     3,542,032   $     7,691,103   $   6,999,324
 
 
 
 

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


  2 


Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

STATEMENTS OF ENTITY EQUITY
(Unaudited)

Contributed Capital
Retained Earnings
Comprehensive Income
Accumulated Other
Comprehensive
Income

Total
Predecessor:
Balance at December 31, 2002
$ 28,316,485   $         139,891                       $           1,065,304   $      29,521,680  
Capital contribution           154,470                      154,470  
Net income  —                    6,999,324   $         6,999,324            6,999,324  
 Foreign currency adjustment       —   4,206,379              4,206,379            4,206,379  
         
         
Comprehensive income
for period from January 1, 2003
through June 30, 2003
    $      11,205,703                           —  
 
 
 
 
 
 
Balance at June 30, 2003 $ 28,470,955   $       7,139,215       $          5,271,683   $     40,881,853  
 
 
     
 
 
                     
Successor:                    
Balance at December 31 2003 $  49,685,601   $      7,357,419       $          3,706,976   $     60,749,996  
                     
Net income  —   7,691,103   $        7,691,103           —   7,691,103  
Foreign currency adjustment   —         —   (1,376,009 (1,376,009 (1,376,009 )
         
         
Comprehensive income for period from January 1, 2004 through June 30, 2004  —         —   $        6,315,094           —    —  
 
 
 
 
 
 
Balance at June 30, 2004 2003 $  49,685,601   $     15,048,522       $          2,330,967   $    67,065,090  
 
 
     
 
 

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


  3 


Bioglan Pharmaceutical Operations of Quintiles Transnational Corp.

STATEMENTS OF CASH FLOWS
(Unaudited)

Six months ended
June 30, 2004

Six months ended
June 30, 2003

 
Successor Predecessor  
Cash flows from operating activities:  
    Net income (loss) $       7,691,103 $   6,999,324  
Adjustments to reconcile net income (loss) to net cash  
    provided by (used in) operating activities:  
    Depreciation                 206,016                  105,346  
    Amortization              3,819,682               3,454,307  
    Allowance for doubtful accounts      —                    24,175  
Changes in operating assets and liabilities:  
    Accounts receivable (5,773,411 )        (2,049,271 )
    Inventories (532,015 )         (903,912 )
    Prepaid expenses and other assets                   30,719                  191,536  
    Accounts payable (271,378 )         (323,472 )
    Accrued expenses (288,213 )         (2,826,336 )
 
 
 
Net cash provided by operating activities               4,882,503              4,671,697  
 
Cash flows from investing activities:  
Purchase of property and equipment  (41,175 )         (246,561 )
 
 
 
Net cash (used in) investing activities (41,175 )    (246,561 )
 
Cash flows from financing activities:  
Repayment of capital lease obligations (8,198 )  —  
Funding from affiliate (5,884,481 ) (4,144,641 )
 
 
 
Net cash (used in) financing activities (5,892,679 ) (4,144,641 )
 
Effect of foreign currency exchange rate changes on cash (44,055 )                    11,754  
 
INCREASE IN CASH AND CASH  EQUIVALENTS (1,095,406 )                  292,250  
   
Cash and cash equivalents at beginning of period               1,540,721                    29,123  
 
 
 
Cash and cash equivalents at end of period $         445,315 $    321,372  
 
 
 

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


  4 


Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp.

NOTES TO FINANCIAL STATEMENTS
(Unaudited)

NOTE A – ORGANIZATION, NATURE OF ENTITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

1. The Entity

The primary business activity of the Bioglan Pharmaceutical Operations of Quintiles Transnational Corp. is the marketing of various dermatology pharmaceutical products, which have been primarily acquired through the purchase or license of trademark rights and patents. These operations are a combination of Quintiles Transnational Corp.’s wholly-owned subsidiary, Bioglan Pharmaceuticals Company, and certain activities conducted at Quintiles Transnational Corp.’s wholly-owned subsidiaries in Ireland and Bermuda (collectively referred to as “Bioglan” or the “Entity”).

2. Basis of Presentation

The accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the six-month period ended June 30, 2004 are not necessarily indicative of the results that may be expected for the year ended December 31, 2004. For further information, refer to the Financial Statements and Notes thereto included in the annual audited statements for the year ended December 31, 2003 of the Bioglan Pharmaceuticals Operations of Quintiles Transnational Corp. The balance sheet at December 31, 2003 has been derived from the audited financial statements of the Entity.

The financial statements for the Entity include the accounts of Bioglan Pharmaceuticals Company and certain accounts from Quintiles Bermuda, Inc. and Bioglan Dublin, Ltd. (a foreign sales corporation). The business units in the preceding sentence are wholly-owned subsidiaries of Quintiles Transnational Corp., (the “Parent”). All inter-entity transactions have been eliminated.

The accompanying financial statements present on a historical basis the financial position, results of operations, changes in equity and cash flows for all periods presented and reflect the “carve out” of the Entity from the consolidated financial statements of the Parent.

Transfers of operating funds between the Entity and the Parent, and the Parent’s various business units occur primarily on a noninterest-bearing basis, with the net amount of these transfers reflected as due to affiliates in the accompanying balance sheet. The net balance in due to affiliates at June 30, 2004 and December 31, 2003, of $15,814,701 and $22,767,167, respectively, is classified as a due to affiliates in the accompanying balance sheets. At June 30, 2004, the Entity has an intercompany note payable denominated in Canadian dollars totaling C$20,000,000 (US$15,052,000) with an annual interest rate of 3% and another non-interest bearing note denominated in Singapore dollars totaling S$50,446,920 (US$29,869,621). This amount in included in the due to affiliates caption in the accompanying balance sheet.

The Parent performed certain limited services and incurred certain costs for the Entity. Services provided include business development, marketing, finance, and human resources. The costs of the services provided by the Parent, have been allocated to the Entity based upon the ratio of net sales of the Entity to the total of the Parent’s consolidated net revenues for certain costs and based upon the Entity’s headcount to the Parent’s consolidated headcount for others. Costs allocated to the Entity for these services are included in the management fee and cost share fee caption in the accompanying statements of operations. In the opinion of management, the method of allocating these costs is believed to be reasonable. However,


  5 


expenses allocated to the Entity are not necessarily indicative of the expenses that would have been incurred on a stand alone basis nor are they indicative of costs that may be charged or incurred in the future.

On September 25, 2003 the Entity’s Parent completed a merger transaction pursuant to which the Parent was acquired by a subsidiary of a newly formed holding company, Pharma Services Holding, Inc. (“Pharma Services”). Pharma Services accounted for the transaction using the purchase method of accounting and therefore allocated the purchase price to the fair values of the Parent’s assets and liabilities on the date of purchase. The purchase accounting related to the September 2003 transaction has been pushed down to the Entity’s separate financial statements. Accordingly, as of September 25, 2003, the Entity has been presented on an entirely new basis of accounting, the Entity’s operations have been identified as predecessor and successor and, where appropriate, separated with a vertical black line.

3. Inventories

The Entity purchases certain raw materials and packaging components from third-party manufacturing vendors. The Entity also utilizes third parties to manufacture and package finished goods held for sale. The Entity takes title to finished goods inventories once manufactured and warehouses such goods until final distribution and sale. Inventories are carried on the books at the lower of cost or market. The Entity provides a reserve for estimated obsolescence or unmarketable inventory, based on a specific identification method, in an amount equal to the cost of the inventory. The Entity uses the first-in-first-out method to remove costs from inventory.

Supplemental information on inventory balances at June 30, 2004 and December 31, 2003 are as follows:

  June 30, 
2004

  December 31,
2003

Finished goods $4,513,235   $ 4,203,936
Raw materials 103,317   44,296
Inventory reserve (204,138)   (367,833)
 
 
Inventories, net $ 4,412,414   $ 3,880,399
 
 
4. Intangible Assets

The Entity has identifiable intangible assets at June 30, 2004 and December 31, 2003 totaling $72,432,003, and $78,651,624, respectively. These assets represent product licenses and distribution rights and were created through the Parent’s acquisition of SkyePharma’s Solaraze® Gel skin treatment in 2001 and certain of the assets of Bioglan Pharma Inc. from Bioglan Plc in 2002. Further, when the Parent completed the transaction with Pharma Services Holding, Inc, the Parent allocated the purchase price to the assets acquired and liabilities assumed based upon their respective fair values as determined by an independent third-party valuation firm as of the date of the acquisition. This allocation included the identifiable intangible assets of Bioglan. As a result, the identifiable intangible assets of Bioglan were increased by a net amount of $11,308,794. The Entity amortizes the intangible assets over the lives, ranging from 9-12 years, of these products. Further, the Parent allocated $530,458 of the goodwill resulting from the Pharma Services transaction (see Note A.2) to the Entity based on the relative fair value of the Entity’s assets to the assets of the Parent’s reporting unit.

The Entity assesses the value of identifiable intangibles whenever events or changes in circumstances indicate that the carrying value may not be recoverable, and that there may have been an other than temporary decline in value. Some factors the Entity considers important which could trigger an impairment review include the following: (i) significant underperformance relative to expected historical or projected future operating results; (ii) significant changes in the manner of use of the acquired assets or the strategy for the Entity’s overall business; and (iii) significant negative industry or economic trends.


  6 


If the Entity were to determine that the carrying value of intangible assets may not be recoverable based upon the existence of one or more of the above indicators of impairment, the Entity would first perform an assessment of the asset’s recoverability based on expected undiscounted future net cash flow, and if the resulting amount is less than the asset’s value, the Entity would measure any other than temporary decline in value based on a projected discounted cash flow method using a discount rate determined by the Entity’s management to be commensurate with the risk inherent in the Entity’s current business model.

5. Risks and Uncertainties

The Entity’s future financial results involve a number of risks and uncertainties. Factors that could affect the Entity’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, maintaining Adoxa® and Solaraze® Gel sales levels, dependence on key personnel, government regulation, manufacturing disruptions, competition, reliance on certain customers and vendors, absence of redundant facilities, and credit risk.

The Entity maintains $30,000,000 of product liability insurance on its products. This insurance is in addition to required product liability insurance maintained by the manufacturers of the Entity’s products. The Entity believes that this amount of insurance coverage is adequate and reasonable, although the Entity cannot assure that product liability claims will not exceed that coverage. In addition, the Entity may not be able to maintain its liability insurance at reasonable premium rates, if at all. To date no product liability claim has been made against the Entity and the Entity is not aware of any pending or threatened claim.

All manufacturers, marketers, and distributors of human pharmaceutical products are subject to regulation by the United States Food and Drug Administration (“FDA”). New drugs are typically subject to an FDA-approved new drug application before being marketed in the United States. Some prescription and other drugs are not the subject of an approved marketing application but, rather, are marketed subject to the FDA’s regulatory discretion and/or enforcement policies. Any change in the FDA’s enforcement discretion and/or policies could alter the way the Entity conducts business and any such change could severely impact the Entity’s future profitability.

6. Stock Based Compensation

The Entity has historically participated in the Parent’s stock option plans to provide incentive compensation to eligible employees, officers and directors in the form of incentive stock options, non-qualified stock options, stock appreciation rights and restricted stock. These plans provided certain employees with options to purchase shares of common stock of the Parent. The Parent’s Board of Directors determined the option price (not to be less than fair market value for incentive options) at the date of grant. Options, particularly those assumed or exchanged as a result of acquisitions, had various vesting schedules and terms. The majority of options granted under the Parent’s stock option plans typically vested 25% per year over four years and expired 10 years from the date of grant. The plan was suspended during 2003 and later terminated due to Pharma Services acquiring all of the issued and outstanding shares of the Parent’s common stock.

The Entity has elected to follow Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB 25”) and related interpretations in accounting for its employee stock options because the alternative fair value accounting provided for under SFAS No. 123, “Accounting for Stock-Based Compensation”, as amended by SFAS No. 148, requires use of option valuation models that were not developed for use in valuing employee stock options. Under APB 25, because the exercise price of the employee stock options equals or exceeds the market price of the underlying stock on the date of grant, no compensation expense is recognized.

Pro forma information regarding net (loss) income is required by SFAS No. 123, as amended by SFAS No.


  7 


148, and has been determined as if the Entity had accounted for the stock options granted by its Parent company and Pharma Services, to the Company’s employees under the fair value method of SFAS No. 123. The following assumptions were used in the Black-Scholes option pricing model when determining pro forma net income:

  Six months ended   Six months ended 
  June 30, 2004
  June 30, 2003
  Successor   Predecessor
Expected dividend yield 0%   0%
Risk-free interest rate 2.7%   1.80%
Expected volatility 65.0%   40.0%
Expected life (in years from end of vesting term) 1.70   0.89

The Black-Scholes option pricing model was developed for use in estimating the fair value of trade options that have no vesting restrictions and are freely transferable. All available option pricing models require the input of highly subjective assumptions including the expected stock price volatility. Because the stock options of Pharma Services granted to the Entity’s employees have characteristics significantly different from those of traded options and changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not provide a reliable single measure of the fair value of the stock options.

  Six months ended
June 30, 2004

  Six months ended
June, 2003

  Successor     Predecessor
 Net income as reported $      7,691,103   $   6,999,324
 Less: pro forma adjustment for stock based
           compensation, net of income tax
                   54,449
 
 
 Pro forma net income $      7,691,103   $   6,944,875
 
 

NOTE B – INTANGIBLE ASSETS

Details of intangible assets are summarized as follows:

  June 30, 2004
  December 31, 2003
  Cost
     Accumulated
Amortization

     Net
     Cost
     Accumulated
Amortization

  Net
      Successor           Successor       
                       
Licenses $78,566,739   $6,134,736   $72,432,003   $81,224,976   $2,573,352   $78,651,624

Licenses are intangible assets with definite useful lives and therefore continue to be amortized under SFAS 142.

NOTE C – RELATED PARTY TRANSACTIONS

As discussed in Note A, the Parent performed certain services and incurred certain costs for the Entity. Services provided include business development, marketing, finance, and human resources. The costs of the services provided by the Parent have been allocated to the Entity based on the net sales or headcount of the Entity relative to the total net sales or headcount of the Parent.


  8 


Costs allocated to the Entity for these services are reflected in the accompanying statements of operations in the management fee and cost share fees caption.

NOTE D – COMMITMENTS AND CONTINGENCIES

1. Legal Proceedings

General Litigation
The Entity is party to other routine actions and proceedings incidental to its business. There can be no assurance that an adverse determination on any such action or proceeding would not have a material adverse effect on the Entity’s business, financial condition or results of operations.

The Entity accounts for legal fees as their services are incurred.

Specific Litigation
The Entity is involved in the following specific litigation: (1) Biogen, Inc. filed before the Trademark Trial and Appeal Board an opposition to Bioglan Pharmaceuticals Company’s pending BIOGLAN PHARMACEUTICALS & Design trademark application, Serial No. 78/136,606, on September 25, 2003, Opposition No. 91157995, and to Bioglan’s pending BIOGLAN PHARMA INC. & Design trademark application, Serial No. 76/099,139, on September 23, 2003, Opposition No. 91158015. Counsel for Bioglan are in discussions in an attempt to resolve this matter; and (2) Bioglan also has received a demand letter from a former employee, claiming gender discrimination. The employee was terminated in February 2004 for performance reasons. The employee was offered to accept one month’s salary as severance in exchange for a signed release in favor of Bioglan. No claim has been filed.

While the Entity’s management currently believes that the ultimate outcome of these proceedings, individually and in the aggregate, will not have a material adverse effect on the Entity’s financial statements, litigation is subject to inherent uncertainties. Were an unfavorable ruling to occur, there exists the possibility of a material adverse impact on the results of operations for the period in which the ruling occurs.

2. Guarantee of Parent Debt

In connection with the Pharma Services transaction (see Note A.2), the Parent issued $450,000,000 of 10% Senior Subordinated Notes due 2013. The Parent and all of its wholly owned domestic subsidiaries (“Guarantors”) have fully and unconditionally guaranteed, on a joint and several basis, the Company’s obligations under the related indentures (the “Guarantees”). Each Guarantee is subordinated in right of payment to the Guarantors’ existing and future senior debt, including obligations under the senior secured credit facility. Bioglan Pharmaceuticals Company is one of the Guarantors under this debt agreement.

NOTE E – SUBSEQUENT EVENT

On June 9, 2004, the Parent entered into an agreement with Bradley Pharmaceuticals (“Bradley”) to sell the assets of the Entity. Under the agreement, Bradley will acquire the Entity’s interests in the dermatology products on the market in the United States, including Solaraze® (diclofenac sodium) Gel, ADOXA® (doxycycline), Zonalon® (doxepin hydrochloride), and TxSystems® for a purchase price of approximately $183 million in cash, plus direct costs for transferred inventory.


  9 


EX-99.5 6 e19367ex99_5.htm PRO FORMA

EXHIBIT 99.5

PRO FORMA FINANCIAL INFORMATION

The following pro forma unaudited consolidated condensed balance sheet has been prepared by taking the June 30, 2004 balance sheet of Bradley Pharmaceuticals, Inc. (“Bradley”) and Bioglan Pharmaceuticals Company (“Bioglan”) and giving effect to the acquisition of substantially all of the assets and assumption of certain liabilities of Bioglan by Bradley as if it had occurred on June 30, 2004. The pro forma consolidated condensed balance sheet has been prepared for information purposes only and does not purport to be indicative of the financial condition that necessarily would have resulted had this transaction taken place on June 30, 2004.

The following pro forma unaudited consolidated condensed statements of income for the year ended December 31, 2003 and the six months ended June 30, 2004 gives effect to Bradley’s acquisition of Bioglan as if it had occurred at January 1, 2003. The net sales and results of operations included in the following pro forma unaudited consolidated condensed statement of income is not considered necessarily indicative of the results of operations for the period specified had the transaction actually been completed at the beginning of such period.

These financial statements should be read in conjunction with the notes to the pro forma unaudited consolidated condensed financial statements, which follow, the financial statements of Bradley and related notes thereto (as previously filed), and the financial statements of Bioglan and related notes thereto, included herewith.


 
   

BRADLEY PHARMACEUTICALS, INC.
UNAUDITED PRO FORMA CONSOLIDATED CONDENSED BALANCE SHEET

    At June 30, 2004

 

  Pro Forma
Adjustments (A)

  Pro Forma
Consolidated

 

  Historical

 

  Bradley
  Bioglan
Assets                            
Current assets:                            

Cash and cash
   
equivalents

   $ 104,360,268    $ 445,315   B&C    $ (96,509,966 )  $ 8,295,617  
Short-term
   investments
    71,572,605             D     (44,129,790 )   27,442,815  
Accounts
   receivable, net
    9,852,563     8,243,192           18,095,755  
Inventories, net     3,192,930     4,412,414             7,605,344  
Deferred tax assets     2,839,719               2,839,719  
Prepaid income taxes     1,432,489               1,432,489  
Prepaid expenses
   and other
    4,761,829     536,023           5,297,852  
   
 
   
 
 
Total current assets     198,012,403     13,636,944       (140,639,756 )   71,009,591  
   
 
   
 
 
Property and
   equipment, net
    1,162,729     714,798           1,877,527  
Intangible assets, net      7,457,784     72,432,003         B     84,567,997      164,457,784  
Goodwill     289,328     530,458         B     20,660,448     21,480,234  
Deferred tax assets     2,238,730               2,238,730  
Deferred financing
   costs
    2,449,995             C     1,887,708     4,337,703  
Other assets     931,810     5,432         E     (925,582 )   11,660  
   
 
   
 
 
Total assets   $ 212,542,779   $ 87,319,635     $ (34,449,185 ) $ 265,413,229  
   
 
   
 
 
                             
Liabilities                            
Current liabilities:                            
Current maturities
   of long-term debt
  $ 90,375   $ 16,667     $   $ 107,042  
Accounts payable     4,028,565     1,142,057           5,170,622  
Accrued expenses     7,078,367     3,248,100   B&F     (1,569,394 )   8,757,073  
Income taxes payable                    
     
 
   
 
 
Total current liabilities     11,197,307     4,406,824       (1,569,394 )   14,034,737  
   
 
   
 
 
Long-term debt, less
current maturities
    35,586     33,020         C     50,000,000     50,068,606  
Convertible senior
subordinated notes
    37,000,000               37,000,000  
Due to affiliate         15,814,701         G     (15,814,701 )    
                             
Stockholders’ Equity                            
Preferred stock                    
Common stock     160,500               160,500  
Class B common stock     4,298               4,298  
Additional paid-in capital     130,789,927               130,789,927  
Contributed capital         49,685,601         G     (49,685,601 )    
Retained earnings     36,149,499     15,048,522         G     (15,048,522 )   36,149,499  
Accumulated other
comprehensive loss
    (532,371 )   2,330,967         G     (2,330,967 )   (532,371 )
Treasury stock     (2,261,967 )             (2,261,967 )
   
 
   
 
 
Total stockholders’
   equity
    164,309,886     67,065,090       (67,065,090 )   164,309,886  
   
 
   
 
 
Total liabilities and
   stockholders’ equity
  $ 212,542,779   $ 87,319,635     $ (34,449,185 ) $ 265,413,229  
   
 
   
 
 

 
   

BRADLEY PHARMACEUTICALS, INC.
UNAUDITED PRO FORMA CONSOLIDATED CONDENSED
STATEMENT OF INCOME
YEAR ENDED DECEMBER 31, 2003

 
Historical
 

 

 

 

 

 

 

 
  Bradley
  Bioglan
  Bioglan
               

 

January 1, 2003
through
December 31,
2003
  September 26,
2003 through
December 31,
2003
  January 1, 2003
through
September 25,
2003
    Pro Forma
Adjustments
  Pro Forma
Consolidated
 
 
 
 
   
 
Net sales

$

74,679,251    $ 18,901,495    $ 33,892,244      $    $ 127,472,990  
Cost of sales

 

6,533,119     4,768,935     8,157,837           19,459,891  
 
 
 
   
 
 

 

 

68,146,132     14,132,560     25,734,407           108,013,099  
 
 
 
   
 
 
Selling, general and
   administrative

 

39,558,738     6,479,929     16,135,900   1   100,000     62,274,567  
Depreciation and
   amortization

 

1,207,116     2,584,036     4,392,194   2   1,632,704     9,816,050  
Gain on investment

 

(312,285 )                 (312,285 )
Interest expense

 

111,847     118,150     63,494   3   3,884,478     4,177,969  
Foreign currency gain

 

    (3,265,609 )   (62,830 ) 4   3,328,439      
 
 
 
   
 
 
 

 

40,565,416     5,916,506     20,528,758       8,945,621     75,956,301  
 
 
 
   
 
 
Income before income
   tax expense

 

27,580,716     8,216,054     5,205,649       (8,945,621 )   32,056,798  
 Income tax expense

 

10,756,000     858,635     786,725   5   292,640     12,694,000  
 
 
 
   
 
 
Net income

$

16,824,716   $ 7,357,419   $ 4,418,924     $ (9,238,261 ) $ 19,362,798  
 
 
 
   
 
 
Basic net income per
   common share

$

1.55                       $ 1.79  
 
                     
 
Diluted net income
   per common share

$

1.35               6       $ 1.54  
 
                     
 
Shares used in computing
   basic net income per
   common share

 

10,820,000                         10,820,000  
 
                     
 
Shares used in computing
   diluted net income per
   common share

 

12,840,000                         12,840,000  
 
                     
 

 
   

BRADLEY PHARMACEUTICALS, INC.
UNAUDITED PRO FORMA CONSOLIDATED CONDENSED
STATEMENT OF INCOME
SIX MONTHS ENDED JUNE 30, 2004

  Historical
           
  Bradley
Bioglan
           
  January 1, 2004
through
June 30, 2004

  January 1, 2004
through
June 30, 2004

      Pro Forma
Adjustments

  Pro Forma
Consolidated

 
Net sales $ 48,022,022    $ 35,983,161         $    $ 84,005,183  
Cost of sales   4,155,482   9,088,616       13,244,098  
 
 
     
 
 
    43,866,540   26,894,545       70,761,085  
 
 
     
 
 
Selling, general and
   administrative
  25,938,734   12,738,611 1   50,000   38,727,345  
Depreciation and
   amortization
  642,479   4,025,698 2   261,646   4,929,823  
Gain on investment   (31,376 )         (31,376 )
Interest expense (income)   (490,018 )   227,840 3   2,657,360   2,395,182  
Foreign currency Loss     681,258 4   (681,258 )    
 
 
     
 
 
    26,059,819   17,673,407     2,287,748   46,020,974  
 
 
     
 
 
Income before income
   tax expense
  17,806,721   9,221,138     (2,287,748 )   24,740,111  
 Income tax expense   7,051,000   1,530,035 5   1,215,965   9,797,000  
 
 
     
 
 
Net income $ 10,755,721 $ 7,691,103   $ (3,503,713 ) $ 14,943,111  
 
 
     
 
 
Basic net income per
   common share
$ 0.69           $ 0.96  
 
             
 
Diluted net income per
   common share
$ 0.61     6     $ 0.84  
 
             
 
Shares used in computing basic
   net income per common share
  15,570,000             15,570,000  
 
             
 
Shares used in computing diluted
   net income per common share
  18,400,000             18,400,000  
 
             
 

 
   

BRADLEY PHARMACEUTICALS, INC.
NOTES TO UNAUDITED PRO FORMA CONSOLIDATED CONDENSED
FINANCIAL STATEMENTS

Pro Forma Adjustments to Balance Sheet

(A)   The accompanying pro forma unaudited consolidated condensed balance sheet has been prepared by taking the June 30, 2004 balance sheet of Bradley and Bioglan and giving effect to the acquisition of substantially all of the assets and assumption of certain liabilities of Bioglan by Bradley as if it had occurred on June 30, 2004. The accompanying pro forma unaudited consolidated condensed statements of income for the year ended December 31, 2003 and the six months ended June 30, 2004 gives effect to Bradley’s acquisition of Bioglan as if it had occurred at January 1, 2003.

  On August 10, 2004, Bradley, through its wholly-owned subsidiary BDY Acquisition Corp., completed the previously announced acquisition of certain assets constituting the “Bioglan business” from Bioglan Pharmaceuticals Company, Quintiles Bermuda Ltd. and Quintiles Ireland Limited, each a subsidiary of Quintiles Transnational Corp. The purchase price of approximately $186 million was paid in cash. The fixed purchase price was allocated among Bioglan assets, including trademarks, patent, core technology and goodwill, based on an independent appraisal obtained.

  The assets acquired include certain intellectual property, regulatory filings, and other assets relating to Solaraze® (diclofenac sodium), a topical treatment indicated for the treatment of actinic keratosis; Adoxa® (doxycycline monohydrate), an oral antibiotic indicated for the treatment of acne; Zonalon® (doxepin hydrochloride), a topical treatment indicated for pruritus; TxSystems®, a line of advanced topical treatments used during in-office procedures; and certain other dermatologic products.

  In connection with the acquisition, Bradley hired certain sales representatives and other personnel of Bioglan and entered into a $50 million bridge credit facility with Wachovia Bank, which replaced Bradley’s existing credit facility with Wachovia. Bradley funded the purchase price for the acquisition through the proceeds of the bridge credit facility and working capital. On September 28, 2004, Bradley replaced the bridge credit facility with a $125 million credit facility, consisting of a $75 million term loan and $50 million revolver, which is not reflected in the pro forma financial information.

  The adjustments below were prepared based on estimates or approximations. It is possible that the actual amounts recorded may have an impact on the results of operations and the balance sheet different from that reflected in the accompanying pro forma unaudited consolidated condensed financials statements. It is therefore possible that the entries below will not be the amounts actually recorded at the closing date.


 
   


(B)   To record the acquisition of substantially all the assets and certain liabilities or Bioglan for a purchase price of $186,392,494 plus acquisition expenses of $2,839,821:

 
  Net assets acquired   $ 67,065,090  
 
             
  Non purchased assets-cash     (445,315 )
             
  Non purchased liabilities:        
             
    Due to affiliate 15,814,701         
             
    Accrued severance 1,569,394      
   
       
        17,384,095  
             
  Increase in net assets for fair
value adjustments Intangibles:
       
             
 
    Currently marketed products
  including patent
84,567,997      
 
             
    Goodwill (i) 20,660,448      
   
       
        105,228,445  
       
 
 
      $ 189,232,315  
       
 
 
             
  Purchase price:        
             
 
    Cash   $ 186,392,494  
 
    Acquisition costs     2,839,821  
       
 
    Cash purchase price   $ 189,232,315  
       
 
    Pro forma adjustment to cash:        
             
    Sale of short-term investments   $ 44,129,790  
    Elimination of Bioglan cash     (445,315 )
    Payment of acquisition costs
  prior to June 30, 2004
    925,582  
    Proceeds from bridge loan     48,112,292  
    Cash purchase price     (189,232,315 )
       
 
    Pro forma adjustment to cash   $ (96,509,966 )
       
 

 
   

  Goodwill represents the amount of the purchase price in excess of Bioglan’s identifiable assets acquired and liabilities assumed. Core technology and trademarks are being amortized over 20 years and the patent is being amortized over 10 years.

(C)   Reflects a $50 million bridge loan and related deferred financing costs.

(D)   Reflects a sale of short-term investments.

(E)   Reflects reclass of acquisition costs rendered prior to Bioglan closing.

(F)   Reflects the elimination of accrued severance obligations payable by the sellers of Bioglan.

(G)   Reflects the elimination of due to affiliate, contributed capital, accumulated other comprehensive loss and retained earnings of Bioglan.

Pro Forma Adjustments to Statements of Income

(1)   Represents administrative services fee to the administration agent for the $50 million bridge loan.

(2)   In connection with the purchase, Bradley recorded approximately $180 million of intangible assets, which represent the amount paid in excess of the fair value of the net tangible assets acquired of Bioglan on the date of the transaction. The value of the intangible assets has been allocated to separately identified intangible assets and goodwill based upon an independent valuation analysis.

  SFAS No. 141 states that goodwill and intangible assets deemed to have indefinite lives will no longer be amortized, but will be subject to annual impairment tests in accordance with the statements. Other intangible assets will continue to be amortized over their useful lives. Thus goodwill related to this merger will not be amortized but will be subject to periodic impairment tests. To the extent the Company is required to pay additional amounts such as contingent consideration or settlement of pre-acquisition contingencies, the amount of goodwill that will be subject to periodic impairment assessments will increase. The intangible assets that do have definite lives are being amortized over estimated useful lives ranging from 10 to 20 years, principally 20 years.

(3)   Represents the reduction of interest income earned on cash and short-term investments and an increase in interest expense related to the $50 million bridge loan at 4.75% utilized to purchase Bioglan and amortization of deferred financing costs associated with the bridge loan.

(4)   Represents the elimination of foreign currency gains or losses because the Company will be operating domestically.

(5)   Represents increasing income tax expense relating to the pre-tax income of Bioglan at a rate of 39.6% for the year ended December 31, 2003 and the six months ended June 30, 2004, respectively.


 
   

(6)   Basic net income per common share is determined by dividing net income by the weighted average number of shares of common stock outstanding. Diluted net income per common share is determined by dividing net income plus applicable after-tax interest expense and related offsets from convertible notes by the weighted number of shares outstanding and dilutive common equivalent shares from stock options, warrants and convertible notes. A reconciliation of the weighted average basic common shares outstanding to weighted average diluted common shares outstanding is as follows:

 

Twelve Months Ended
December 31, 2003

  Six Months Ended
June 30, 2004

 

Historical
  Pro Forma
  Historical
  Pro Forma
Basic shares 10,820,000    10,820,000    15,570,000    15,570,000
Dilution:              
Stock options and warrants 1,070,000   1,070,000   980,000   980,000
Convertible notes 950,000   950,000   1,850,000   1,850,000
 
 
 
 
Diluted shares 12,840,000   12,840,000   18,400,000   18,400,000
 
 
 
 
Net income $ 16,824,716   $ 19,362,798   $ 10,755,721   $ 14,943,111
After-tax interest expense
   and other from
   convertible notes
447,160   447,160   507,446   507,446
 
 
 
 
Adjusted net income $ 17,271,876   $ 19,809,958   $ 11,263,167   $ 15,450,557
 
 
 
 
Basic income per share $            1.55   $            1.79   $            0.69   $            0.96
 
 
 
 
Diluted income per share $            1.35   $            1.54   $            0.61   $            0.84
 
 
 
 

 
   

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