EX-99.3 4 a51656exv99w3.htm EXHIBIT 99.3 exv99w3
Exhibit 99.3
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS
     The following unaudited pro forma condensed financial statements combine the historical financial statements of Spectrum Pharmaceuticals, Inc. and the historical statement of net revenues and direct expenses of the Zevalin Business, including certain estimates, assumptions and adjustments described in the accompanying notes to the pro forma condensed combined financial information. The Zevalin Business is being conducted by a 50/50-owned joint venture called RIT Oncology, LLC (the “Joint Venture”) of which Spectrum and Cell Therapeutics, Inc. (“CTI”) were each issued a 50% membership interest upon the closing of the Joint Venture transaction on December 15, 2008.
For pro forma purposes:
    Spectrum’s unaudited balance sheet as of September 30, 2008 has been adjusted to reflect pro forma adjustments as if the Joint Venture transaction had occurred on September 30, 2008;
 
    Spectrum’s unaudited statement of operations for the nine months ended September 30, 2008 has been combined with Zevalin’s audited statement of net revenues and direct expenses for the nine months ended September 30, 2008 as if the Joint Venture transaction had occurred on January 1, 2008;
    Spectrum’s unaudited statement of operations for the year ended December 31, 2007 has been combined with Zevalin’s statement of net revenues and direct expenses for the nine months ended September 30, 2008 to represent combined results of operations as if the Joint Venture transaction had occurred on January 1, 2007, and assumes that the Zevalin business performance was similar to 2008.
     The unaudited pro forma condensed combined financial information is intended for informational purposes only and does not purport to represent what Spectrum’s financial position or results of operations would actually have been if the Joint Venture transaction had in fact occurred on the dates indicated above, and should not be construed as being representative of future operating results.
     Also, these unaudited pro forma condensed combined financial statements and accompanying notes should be read in conjunction with the historical financial statements and the related notes included in Spectrum’s Annual Report on Form 10-K for the year ended December 31, 2007, its quarterly report on Form 10-Q for the nine months ended September 30, 2008 and the statements of net revenues and direct expenses and related disclosure of the Zevalin Business for the nine months ended September 30, 2008.

 


 

UNAUDITED PRO FORMA CONDENSED
COMBINED BALANCE SHEET
September 30, 2008
(In thousands)
                                         
    Spectrum      Zevalin                      
    Pharmaceuticals,     Business     Pro Forma             Pro Forma  
    Inc.     Note 1       Adjustments     Note 2     Combined  
ASSETS  
                                             
Current assets:
                                       
Cash and marketable securities
  $ 51,636     $     $ (15,000 )     (A )   $ 36,636  
Accounts receivable-trade, net of allowance for doubtul accounts
    186                           186  
Inventory
    1,446                           1,446  
Prepaid expenses and other current assets
    254                           254  
 
                               
 
                                       
Total current assets
    53,522             (15,000 )             38,522  
Property and equipment, net
    1,633                           1,633  
Intangible Assets, net
          37,200             (B )     37,200  
Other assets and deferred charges
    143                           143  
 
                               
 
                                       
Total assets
  $ 55,298     $ 37,200     $ (15,000 )           $ 77,498  
 
                               
 
                                       
LIABILITIES AND SHAREHOLDERS’ DEFICIT
                                       
Current liabilities:
                                       
Accounts payable and accrued expenses
  $ 7,934     $ 2,200             (C )   $ 10,134  
 
                               
 
                                       
Deferred revenue and other credits
    1,026                           1,026  
 
                               
 
                                       
Total liabilities
  $ 8,960     $ 2,200     $             $ 11,160  
 
                               
 
                                       
Commitments and contingencies
   $      $ 9,700      $       (D )    $ 9,700  
 
                               
Minority interest in Joint Venture
   $      $      $ 12,650       (A )    $ 12,650  
 
                               
Preferred stock
    419                           419  
Common stock
    32       30,000       (30,000 )     (A )     32  
Additional paid-in capital
    294,051                           294,051  
Accumulated other comprehensive income
    390                           390  
Accumulated deficit
    (248,554 )     (4,700 )     2,350       (B )     (250,904 )
 
                               
 
                                       
Total stockholders’ equity
    46,338       25,300       (27,650 )             43,988  
 
                               
 
                                       
Total liabilities and stockholders’ equity
  $ 55,298     $ 37,200     $ (15,000 )           $ 77,498  
 
                               


 

UNAUDITED PRO FORMA CONDENSED
COMBINED STATEMENT OF OPERATIONS
NINE MONTHS ENDED SEPTEMBER 30, 2008
(In thousands, except per share amounts)
                                         
    Spectrum     Zevalin                      
    Pharmaceuticals,     Business     Pro Forma             Pro Forma  
    Inc.     Note 1     Adjustments     Note 2     Combined  
Revenues:
                                       
Licensing and milestone revenues
  $ 20,676     $     $             $ 20,676  
Product sales
          8,824                     8,824  
 
                             
 
                                       
Total revenues
    20,676       8,824                     29,500  
 
                             
 
                                       
Operating expenses:
                                       
Cost of product sold
          2,349                     2,349  
Research and development
    19,089       5,674                     24,763  
Selling, general and administrative
    8,947       6,519                     15,466  
Amortization of purchased intangibles
          519       2,181       (E )     2,700  
 
                             
 
                                       
Total operating expenses
    28,036       15,061       2,181               45,278  
 
                             
 
                                       
Loss from operations
    (7,360 )     (6,237 )     (2,181 )             (15,778 )
Other income, net
    556                           556  
 
                             
 
                                       
Net loss before minority interest
    (6,804 )     (6,237 )     (2,181 )             (15,222 )
 
                             
 
                                       
Minority interest
            3,118       1,090       (F )     4,208  
 
                             
 
                                       
Net loss attributable to common stockholders
  $ (6,804 )   $ (3,119 )   $ (1,091 )           $ (11,014 )
 
                             
 
                                       
Basic and diluted net loss per common share
  $ (0.22 )                           $ (0.35 )
 
                                   
 
                                       
Shares used in calculation of basic and diluted net loss per common share
    31,424,358                               31,424,358  
 
                                   


 

UNAUDITED PRO FORMA CONDENSED
COMBINED STATEMENT OF OPERATIONS
YEAR ENDED DECEMBER 31, 2007
(In thousands, except per share amounts)
                                         
    Spectrum     Zevalin                      
    Pharmaceuticals,     Business     Pro Forma             Pro Forma  
    Inc.     Note 1     Adjustments     Note 2     Combined  
Revenues:
                                       
Licensing and milestone revenues
  $ 7,672     $     $             $ 7,672  
Product sales
          8,824                     8,824  
 
                               
 
                                       
Total revenues
    7,672       8,824                     16,496  
 
                               
 
                                       
Operating expenses:
                                       
Cost of product sold
          2,349                     2,349  
Research and development
    33,285       5,674                     38,959  
Selling, general and administrative
    11,582       6,519                     18,101  
Amortization of purchased intangibles
          519       3,081       (E )     3,600  
 
                               
 
                                       
Total operating expenses
    44,867       15,061       3,081               63,009  
 
                               
 
                                       
Loss from operations
    (37,195 )     (6,237 )     (3,081 )             (46,513 )
Other income, net
    3,139                           3,139  
 
                               
 
                                       
Liabilities and shareholders’ deficit
    (34,056 )     (6,237 )     (3,081 )             (43,374 )
 
                               
 
                                       
Minority interest
    20       3,118       1,540       (F )     4,678  
 
                               
 
                                       
Net loss before minority interest
  $ (34,036 )   $ (3,119 )   $ (1,541 )           $ (38,696 )
 
                               
 
                                       
Basic and diluted net loss per common share
  $ (1.17 )                           $ (1.33 )
 
                                   
 
                                       
Shares used in calculation of basic and diluted net loss per common share
    29,013,850                               29,013,850  
 
                                   


 

Notes to Unaudited Pro Forma
Condensed Combined Statements of Operations
Note 1. The Zevalin Business
     On December 15, 2008, Spectrum Pharmaceuticals, Inc. (“Spectrum” or “the Company”) closed a transaction to enter into a 50/50-owned joint venture (the “Joint Venture”) whose purpose is to commercialize and develop Zevalin (ibritumomab tiuxetan), or Zevalin (the “Zevalin Business”) in the United States. The Joint Venture is being conducted through a newly-formed Delaware limited liability company, RIT Oncology, LLC (“RIT”), of which Spectrum and CTI were each issued a 50% membership interest upon the closing of the Joint Venture transaction.
     Pursuant to the Purchase and Formation Agreement (the “Joint Venture transaction”) dated as of November 26, 2008, Spectrum contributed $15 million as initial consideration for 50% interest in the Joint Venture. Accordingly, the initial capitalization of the Joint Venture was recorded as $30 million. Additionally, CTI has the option to sell its 50% membership interest in the Joint Venture to Spectrum. CTI exercised this Put Option on February 20, 2009, and Spectrum has 30 days to accept the Put. Therefore, the accompanying proforma financial information is presented on the basis of the Zevalin Business being consolidated into Spectrum Pharmaceuticals, Inc., with CTI’s interest in the Joint Venture presented as a Minority Interest.
     CTI contributed to the Joint Venture all of its interests in the Zevalin Business, which included the following: (i) Assets acquired in the December 2007 agreement with Biogen Idec Inc., or Biogen, which included the U.S. development, sales and marketing rights to Zevalin. The assets acquired included the Zevalin FDA registration, FDA dossier, U.S. trademark, trade name and trade dress, customer list, certain patents and the assignment of numerous contracts. There was no continuity of physical facilities or personnel from that acquisition. (ii) Assets acquired in the June 2008 Access Agreement with Bayer Schering Pharma AG, or Bayer, which holds the rights to Zevalin outside of the United States. Under the agreement, Bayer gave CTI access to data from Bayer’s phase III first-line indolent trial, or FIT trial, of Zevalin. And (iii) CTI’s September 30, 2008 submission of a supplemental biologics license application, or sBLA, for use of Zevalin in consolidation therapy of first remission in advanced stage follicular NHL. The FDA has granted priority review status for this sBLA and a decision is targeted for July 2009. The Joint Venture also assumed certain obligations as follows: $2.2 million current liabilities, and $16 million contingent obligations.
     The allocation of the initial capitalization of the Joint Venture, detailed below, was based on the relative fair values of the intangible assets acquired, as determined by an independent valuation consultant, and the obligations assumed by the Joint Venture.
                 
Developed technology
          $ 23,100  
Core technology
            14,100  
Acquired in-process research and development
            4,700  
Assumed Obligation to pay Biogen
            (2,200 )
Assumed Contingent Obligations
  $ 12,500          
Less: Limitation based on excess of values of Intangibles acquired over Initial capitalization
    (2,800 )        
 
             
Contingent Obligations, as recorded
            (9,700 )
 
             
 
               
Total initial capitalization of Joint Venture
          $ 30,000  
 
             
     The total fair value of intangible assets equals $41.9 million which includes developed technology, core technology and acquired in-process research and development. The developed technology asset relates to intellectual property and rights thereon related to Zevalin as approved by the FDA for relapsed or refractory low-

 


 

grade, follicular, or B-cell NHL. The core technology asset represents the value of the intellectual property and rights thereon expected to be leveraged in the development of label expansions for Zevalin. Developed and core technologies will be amortized over the term of the patents related to such technologies. We estimate aggregate amortization expense related to these acquired intangible assets to be $3.6 million annually. In-process research and development (IPRD) for the Joint Venture transaction was evaluated utilizing the present value of the estimated after-tax cash flows expected to be generated by purchased undeveloped technology related to the Zevalin Business or label expansions for indications that have not been approved by the FDA. Since, at the effective time of the Joint Venture transaction, the IPRD had not reached technological feasibility, such amount has been charged to retained earnings as of the formation date of the Joint Venture.
     Because the Joint Venture transaction involves contingent consideration, the Company recognized $9.7 million contingent obligation which is equal to the excess of the fair value of the intangible assets over the initial capitalization, and is less than the approximately $12.5 million fair value of the contingent consideration, as determined by the independent valuation consultant. When the contingencies are resolved and the contingent consideration becomes payable, any excess of the fair value of the contingent consideration over the amount initially recognized as a liability shall be recognized as an additional cost of the acquired entity. If the amount initially recognized as a liability exceeds the fair value of the contingent consideration, that excess will be allocated as a pro rata reduction of the amounts assigned to the assets acquired.
Note 2. Pro Forma Adjustments
     The pro forma amounts and adjustments included in the unaudited pro forma condensed combined financial statements are as follows:
(A)   Adjustment to record the initial contribution to the Joint Venture of $15 million in consideration for Spectrum’s 50% interest in the Joint Venture. In addition, given the accounting for the Joint Venture as a consolidated entity, the $30 million initial capitalization of the Zevalin Business is eliminated, and CTI’s 50% interest in the Joint Venture is classified as $15 million Minority Interest in Joint Venture less its 50% share of the IPR&D charge of $2.35 million.
 
(B)   To record Zevalin’s $41.9 million of Intangible Assets representing $23.1 million in developed technology and $14.1 million in core technology, and after the $4.7 million write-off of in-process research and development (IPR&D) as of the formation date.
 
(C)   To record $2.0 million in Zevalin milestone fees paid to Biogen by RIT (as successor to CTI) pursuant to the First Amendment to Asset Purchase Agreement, dated as of December 9, 2008. Amount also includes $200,000 reimbursement to CTI by RIT from the initial capital contributions made by Spectrum and CTI. The $200,000 amount was a payment required by Biogen for consenting to the Joint Venture.
 
(D)   To record contingent consideration of $9.7 million based on the excess of the fair value of the intangible assets over the initial capitalization.
 
(E)   Adjustment to record $2.7 million amortization for the acquired intangible assets for the nine months ended September 30, 2008, and $3.6 million for the year ended December 31, 2007.
 
(F)   To record CTI’s 50% Minority Interest in the Joint Venture for the periods presented.
There is no income tax adjustment related to the pro forma adjustments due to the assumption that the tax benefit generated by the Zevalin Business losses would require a full valuation allowance.