8-K/A 1 w93994e8vkza.htm FORM 8-K/A e8vkza
 


SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K/A

CURRENT REPORT

Current Report Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

February 27, 2004
(Amending report originally dated November 12, 2003
and amended January 12, 2004)

GUILFORD PHARMACEUTICALS INC.

(Exact name of registrant as specified in its
charter)

         
Delaware   0-23736   52-1841960

(State or other jurisdiction of   (Commission File Number)   (I.R.S. Employer
incorporation or organization)       Identification No.)
     
6611 Tributary Street    
Baltimore, Maryland   21224

(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (410) 631-6300


(Former name or former address, if changed since last report)


Exhibit Index is on page 10.

 


 

INFORMATION TO BE INCLUDED IN THE REPORT

Item 7. Financial Statements, Pro Forma Financial Information and Exhibits

     On November 12, 2003, the Company filed a current report on Form 8-K (the “Original Report”) regarding its October 28, 2003, acquisition of the rights to AGGRASTAT® Injection (“AGGRASTAT®”), from Merck and Co., Inc., in the United States and its territories and possessions which include Puerto Rico, the U.S. Virgin Islands and Guam. On January 12, 2004, the Company filed a report on Form 8-K/A (the “First Amendment”) to amend and supplement Item 7 of the Original Report to include certain financial information required by Items 7(a) and (b) of Form 8-K. The Company is filing this report amending Item 7(b) of Form 8-K/A to eliminate the liability for the net present value of royalties owed to Merck and Co., Inc. on future sales of AGGRASTAT® and associated interest expense contained in the pro forma financial information.

     
(b)   Pro forma financial information, as amended
     
    Unaudited Pro Forma Condensed Balance Sheet as of September 30, 2003 of Guilford Pharmaceuticals Inc.
     
    Unaudited Pro Forma Condensed Statement of Operations for the Nine Months Ended September 30, 2003 of Guilford Pharmaceuticals Inc.
     
    Unaudited Pro Forma Condensed Statement of Operations for the Year Ended December 31, 2002 of Guilford Pharmaceuticals Inc.
     
(c)   Exhibits
     
    23.01 Consent of Eisner LLP

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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES

PRO FORMA FINANCIAL INFORMATION (UNAUDITED)

     The following unaudited pro forma condensed statements of operations for the nine months ended September 30, 2003 and for the year ended December 31, 2002, give the effect to the acquisition of AGGRASTAT® Injection (“AGGRASTAT®”) product rights as if such acquisition had occurred at the beginning of the respective periods. The following unaudited pro forma condensed balance sheet as of September 30, 2003, gives effect to the AGGRASTAT® product rights acquisition as if it had occurred on September 30, 2003.

     The pro forma adjustments are based upon available information and certain assumptions that management believes are reasonable under the circumstances. The pro forma adjustments were applied to the respective historical financial statements to reflect and account for the acquisition using the purchase method of accounting. The pro forma statement of operations excludes material non-recurring charges of $8.1 million related to acquired in-process research and development. The pro forma financial information is not necessarily indicative of the operating results or financial position that would have been achieved had the acquisition been consummated on the dates indicated and should not be construed as representative of future operating results or financial position. Specifically, Guilford Pharmaceuticals Inc. (“the Company”) expects to incur additional selling expenses related to its promotional efforts for the acquisition on an ongoing basis, in addition to up-front costs expected to be incurred related to the initial launch of this product. The purchase price was allocated to intangible assets acquired based on their respective fair values as determined in a valuation study performed by a third party and management’s evaluation of the assets and liabilities. The purchase price allocation among the intangible assets acquired and the assignment of lives of these intangible assets are subject to change based upon further evaluation.

     The unaudited pro forma condensed financial statements should be read in conjunction with the Company’s Consolidated Financial Statements and related Notes thereto, Management’s Discussion and Analysis of Financial Condition and Results of Operations included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2002 and the Quarterly Report on form 10-Q for the quarter ended September 30, 2003.

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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES

Unaudited Pro Forma Condensed Balance Sheet
As of September 30, 2003
(in thousands)

                                               
         
                           
         
Guilford
         
Pro Forma
   
          Pharmaceuticals Inc.           Adjustments   Pro Forma
         
         
 
   
ASSETS
                
       
                                   
Current assets:
                                       
 
Cash, cash equivalents and investments, net
          $ 110,834             $ (45,990 ) (a)   $ 64,844  
 
Accounts receivable, net
            771                     771  
 
Inventories, net
            2,166                     2,166  
 
Prepaid expenses and other current assets
            2,154                     2,154  
 
 
           
           
     
 
     
Total current assets
            115,925               (45,990 )     69,935  
Investments – restricted
            22,021                     22,021  
Property and equipment, net
            23,216                     23,216  
Intangible assets and other assets, net
            10,514               79,896 (b)     90,410  
 
 
           
           
     
 
 
         
$
171,676             $ 33,906     $ 205,582  
 
 
           
             
     
 
   
LIABILITIES AND STOCKHOLDERS’ EQUITY
                
       
Current liabilities:
                                       
 
Accounts payable
          $ 4,947            
 $
    $ 4,947  
 
Current portion of long-term debt
            3,651                     3,651  
 
Accrued expenses and other current liabilities
            8,081                     8,081  
 
 
           
           
     
 
 
Total current liabilities
            16,679                     16,679  
Long-term debt, net of current portion
            89,352                     89,352  
Other liabilities
            1,386                     1,386  
Revenue interest obligation
                          40,774 (c)     40,774  
 
 
         
           
     
 
     
Total liabilities
            107,417               40,774       148,191  
 
 
         
           
     
 
     
Stockholders’ equity
            64,259               (6,868 ) (d)     57,391  
 
 
         
           
     
 
 
         
$
171,676             $ 33,906     $ 205,582  
 
 
           
             
     
 

The accompanying notes are an integral part of this unaudited pro forma condensed balance sheet.

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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES

Unaudited Pro Forma Condensed Statement of Operations
For the Nine Months Ended September 30, 2003
(in thousands, except per share data)

                                             
        Guilford   Aggrastat   Pro Forma    
        Pharmaceuticals Inc.   Product Line   Adjustments   Pro Forma
       
 
 
 
Revenues:
                                       
 
Net product sales
  $ 13,708     $ 18,392                   $ 32,100  
 
Revenues from license fees and milestones
    5,777                           5,777  
 
 
   
     
     
             
 
   
Total revenues
    19,485       18,392                     37,877  
Costs and Expenses:
                                       
 
Cost of sales
    2,899       857                     3,756  
 
Research and development
    24,253                           24,253  
 
Selling, general and administrative
    22,250       142                     22,392  
 
Intangible amortization
    630             4,509   (e)             5,139  
 
 
   
     
     
             
 
   
Total costs and expenses
    50,032       999       4,509               55,540  
 
 
   
     
     
             
 
Operating income (loss)
    (30,547 )     17,393       (4,509 )             (17,663 )
Other income (expense):
                                       
 
Investment income
    2,361                           2,361  
 
Revenue interest expense
                (7,126 )(f)           (7,126 )
 
Interest expense
    (1,643 )                       (1,643 )
 
 
   
     
     
             
 
Net income (loss)
  $ (29,829 )   $ 17,393     $ (11,635 )           $ (24,071 )
 
 
   
     
     
             
 
Basic and diluted loss per common share:
  $ (1.01 )                       $ (0.81 )
 
 
   
                             
 
Weighted-average shares outstanding to compute basic and diluted loss per share
    29,541               (g)             29,541  
 
 
   
                             
 

The above unaudited pro forma condensed statement of operations excludes the impact of non-recurring charges of $8.1 million for Acquired in-process research and development.

The accompanying notes are an integral part of this unaudited pro forma condensed statement of operations.

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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES

Unaudited Pro Forma Condensed Statement of Operations
For the Year Ended December 31, 2002
(in thousands, except per share data)

                                         
        Guilford   Aggrastat   Pro Forma        
        Pharmaceuticals Inc.   Product Line   Adjustments       Pro Forma
       
 
 
     
Revenues:
                                   
 
Net product sales
  $ 14,538     $ 54,764     $         $ 69,302  
 
Revenues from license fees and milestones
    127                       127  
 
 
   
     
     
         
 
   
Total revenues
    14,665       54,764                 69,429  
Costs and Expenses:
                                   
 
Cost of sales
    2,836       2,133                 4,969  
 
Research and development
    46,103                       46,103  
 
Selling, general and administrative
    29,005       16,636                 45,641  
 
Intangible amortization
    840             6,012   (e )     6,852  
 
 
   
     
     
         
 
   
Total costs and expenses
    78,784       18,769       6,012           103,565  
         
     
     
         
 
Operating income (loss)
    (64,119 )     35,995       (6,012 )         (34,136 )
Other income (expense):
                                   
 
Investment income
    5,350                       5,350  
 
Revenue interest expense
                (9,501 ) (f )     (9,501 )
 
Interest expense
    (501 )                 (501 )
 
 
   
     
     
         
 
Net income (loss)
  $ (59,270 )   $ 35,995     $ (15,513 )       $ (38,788 )
 
 
   
     
     
         
 
Basic and diluted loss per common share:
  $ (1.99 )                   $ (1.30 )
 
 
   
                         
 
Weighted-average shares outstanding to compute basic and diluted loss per share
    29,805               (g )     29,805  
 
 
   
                         
 

The above unaudited pro forma condensed statement of operations excludes the impact of non-recurring charges of $8.1 million for Acquired in-process research and development.

The accompanying notes are an integral part of this unaudited pro forma condensed statement of operations.

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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES

Notes to Unaudited Pro Forma Condensed Balance Sheet and Statements of Operations

Following is a summary of the purchase price in millions:

         
Cash consideration, including $42.0 million received from a revenue
       
interest financing arrangement entered into with Paul Royalty Fund, L.P.
       
and certain of its affiliated entities, collectively known as “PRF”
  $ 84.0  
Estimated transaction fees
    2.2  
 
   
 
 
  $ 86.2  
 
   
 

The allocation of the purchase price of the AGGRASTAT® Injection (“AGGRASTAT®”) acquisition is as follows:

         
Intangible assets
  $ 78.1  
Acquired in-process research and development
    8.1  
 
   
 
 
  $ 86.2  
 
   
 

     At the date of acquisition, the development of AGGRASTAT® for use in Percutaneous Coronary Intervention (“PCI”) was not complete, had not reached technological feasibility and had no known alternative future uses. Consequently, there is considerable uncertainty as to the technological feasibility of the product for this indication at the date of acquisition. The Company does not foresee any alternative future benefit from the acquired research and development other than specifically related to the PCI indication under development. Significant technological and regulatory approval risk are associated with the development of the product for a PCI indication. Achieving such an indication will require significant amounts of future time, effort, and substantial development costs, which will be incurred by the Company. The efforts required to develop the acquired research and development into commercially viable products include the completion of the clinical-trial testing, regulatory approval and commercialization. The principal risks relating to achieving the indication under development are the outcomes of clinical studies and regulatory filings. Since pharmaceutical products cannot be marketed without regulatory approvals, the Company will not receive any benefits unless regulatory approval is obtained. Accordingly, the portion of the purchase price related to these products under development was allocated to acquired in-process research and development and was expensed at the date of acquisition.

(a)   Represents Guilford’s use of $42.0 million cash to finance the acquisition of the AGGRASTAT® product rights as well as approximately $4.0 million of costs related to the PRF financing of approximately $1.8 million and acquisition costs of $2.2 million noted above.

(b)   Represents the intangible assets acquired as part of the AGGRASTAT® acquisition ($78.1 million) plus deferred financing costs associated with the PRF revenue interest obligation ($1.8 million).

(c)   Represents the revenue interest sold to PRF ($42.0 million) net of the value allocated to the five year warrants to purchase 300,000 shares of the Company’s common stock at $9.15 per share. The allocation was determined based upon the relative fair values of the two financial instruments at the time of issuance. While the Company has minimum payments within one year of the balance sheet presented, the accretion of interest will exceed such payments and the revenue interest will increase during the earlier years of the relationship.

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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES

Notes to Unaudited Pro Forma Condensed Balance Sheet and Statements of Operations

     
(d)   Represents the write-off of acquired in-process research and development ($8.1 million) net of the allocated value assigned to the warrants ($1.2 million) included as part of the PRF revenue interest obligation transaction.
     
(e)   Represents the amortization of intangible assets acquired in connection with the acquisition based on the preliminary purchase price allocation over their estimated useful lives.
                                   
                      For the nine months ended   For the year ended
      Fair Value of           September 30, 2003   December 31, 2002
Intangible   Intangibles   Estimated Life   Amortization   Amortization

 
 
 
 
            (in years)   (dollars in millions)        
Patents (1)
  $ 53.4       13     $ 3.1     $ 4.1  
Trademarks (2)
    9.7       13       0.6       0.8  
Customer contracts and related relationships (2)
    14.7       13       0.8       1.1  
Other
    0.3       11       0.0       0.0  
 
   
             
     
 
 
Total
  $ 78.1             $ 4.5     $ 6.0  

(1)   Certain core formulation patents that cover the product expire in 2016.

(2)   The expected lives of the intangible assets relate to the lives of the patents, and therefore have a consistent estimated life.

(f)   Represents effective interest expense related to the PRF revenue interest obligation and amortization of deferred financing costs associated with the acquisition.

(g)   The transaction was financed by cash, the long-term revenue interest obligation and associated warrants. As no common stock was issued and the Company has a pro forma loss, there is no pro forma impact on the weighted average shares outstanding or loss per share.

Certain prior year amounts of Guilford Pharmaceuticals Inc. have been reclassified to conform with the current year presentation.

-8-


 

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.

         
 
    GUILFORD PHARMACEUTICALS INC.
 
Dated: February 27, 2004 By: /s/ Andrew R. Jordan
     
        Andrew R. Jordan
Executive Vice President, Chief
Financial Officer and Treasurer

-9-


 

INDEX TO EXHIBITS

     
Exhibit    
Number  
Exhibit Description
     
23.01   Consent of Eisner LLP

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