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8-K/A - 8-K/A - MEDIVATION, INC.d100084d8ka.htm
EX-99.1 - EX-99.1 - MEDIVATION, INC.d100084dex991.htm
EX-23.1 - EX-23.1 - MEDIVATION, INC.d100084dex231.htm
EX-99.2 - EX-99.2 - MEDIVATION, INC.d100084dex992.htm

Exhibit 99.3

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

Introductory Note

Description of the Transaction

On August 21, 2015, Medivation, Inc. (the “Company”) entered into an Asset Purchase Agreement (the “Agreement”) with BioMarin Pharmaceutical Inc. (“BioMarin”) pursuant to which the Company acquired all rights to talazoparib (“talazoparib research program”), an orally available poly-ADP ribose polymerase (“PARP”) inhibitor from BioMarin. The acquired talazoparib assets include all patents, data, know-how, third party agreements, regulatory materials, and pre-commercial inventories. The Company also assumed certain costs related to talazoparib to the extent they arise after the closing of the transaction, including costs for the ongoing clinical trials of talazoparib, and commitments under certain agreements previously entered into by BioMarin and assigned to the Company.

On October 6, 2015, the Company completed the acquisition of the talazoparib research program from BioMarin. In connection with the closing of the transaction, the Company paid BioMarin an upfront cash payment of $410.0 million, and will pay BioMarin up to an additional $160.0 million upon the achievement of defined regulatory and sales-based milestones, and mid-single digit royalties on net sales of products that contain talazoparib during the royalty term specified in the Agreement.

Basis of Presentation

The determination of the accounting for the talazoparib research program acquisition as a business acquisition was based on a review of all of the pertinent facts and circumstances and was based on a number of factors outlined in Financial Accounting Standards Board Accounting Standards Codification (“ASC”) 805, “Business Combinations,” which provides guidance in identifying a transaction as an asset acquisition or a business acquisition. After consideration of the factors outlined in the prescribed ASC guidance as well as the state of the development of the late-stage molecule acquired from BioMarin pursuant to the Agreement, it was determined that the talazoparib research program acquisition should be accounted for as a business acquisition and accounted for using the “acquisition method” of accounting.

The following unaudited pro forma condensed combined financial statements combine the historical financial information of the Company and the talazoparib research program. The unaudited pro forma condensed combined balance sheet at September 30, 2015 gives effect to the acquisition as if the acquisition had been consummated on that date. The unaudited pro forma condensed combined statements of operations for the year ended December 31, 2014 and the nine months ended September 30, 2015 are presented as if the acquisition had been completed on January 1, 2014. The unaudited pro forma condensed combined financial statements were prepared using the acquisition method of accounting are also in accordance with Article 11 of Regulation S-X.

The unaudited pro forma condensed combined financial information presented below is based on, and should be used in conjunction with (i) the Company’s historical audited consolidated financial statements, and related notes thereto, for the year ended December 31, 2014, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, (ii) the Company’s historical unaudited condensed consolidated financial statements, and related notes thereto, for the nine months ended September 30, 2015, included in the Company’s Quarterly Report for the nine months ended September 30, 2015, (iii) the historical audited financial statements, and related notes thereto, of the talazoparib research program for the year ended December 31, 2014 included as Exhibit 99.1 to this Form 8-K/A, and (iv) the historical unaudited financial statements, and related notes thereto, of the talazoparib research program for the nine months ended September 30, 2015 included as Exhibit 99.2 to this Form 8-K/A.

The Company is not aware of any material differences between the accounting policies of the Company and the talazoparib research program. Accordingly, the accompanying unaudited pro forma condensed combined financial statements do not assume any material differences in accounting policies between the Company and the talazoparib research program. The Company has not finalized its review of the historical accounting policies of the talazoparib research


program. Any differences between the Company’s accounting policies and the talazoparib research program’s historical accounting policies could be significant. The unaudited pro forma condensed combined financial information should be read in conjunction with the accompanying notes.

The Company’s historical consolidated financial information has been adjusted to give effect to pro forma events that are (1) directly attributable to the transaction, (2) factually supportable, and (3) with respect to the statements of operations, expected to have a continuing impact on the combined results. The unaudited pro forma condensed combined financial statements do not reflect the realization of potential cost savings, or any related restructuring costs, integration costs, or transition costs that may result from the transaction. These unaudited pro forma condensed combined financial statements are not necessarily indicative of the results of operations that would have been achieved had the transaction actually take place at the dates indicated and do not purport to be indicative of future financial position or operating results. The unaudited pro forma condensed combined financial information includes adjustments which are preliminary and may be revised, and any revisions could be material.


MEDIVATION, INC.

UNAUDITED PRO FORMA CONDENSED COMBINED

BALANCE SHEET

AS OF SEPTEMBER 30, 2015

(in thousands)

 

     Medivation, Inc.
(Historical)
     Talazoparib
Research Program
(Historical)
    Pro Forma
Adjustments
    See Note
4
   Pro Forma
Combined
 

ASSETS

            

Current assets:

            

Cash and cash equivalents

   $ 488,944       $ —        $ (410,000   (a)    $ 78,944   

Receivable from collaboration partner

     277,612         —          —             277,612   

Deferred income tax assets

     22,353         —          —             22,353   

Prepaid expenses and other current assets

     15,946         814        (814   (b)      15,946   

Restricted cash

     930         —          —             930   
  

 

 

    

 

 

   

 

 

      

 

 

 

Total current assets

     805,785         814        (410,814        395,785   

Property and equipment, net

     49,018         —          —             49,018   

Intangible assets

     101,000         35,150        538,149      (c)      674,299   

Deferred income tax assets, non-current

     35,628         —          —             35,628   

Restricted cash, net of current

     12,206         —          —             12,206   

Goodwill

     10,000         16,328        (7,685   (d)      18,643   

Other non-current assets

     6,957         1,070        (1,070   (b)      6,957   
  

 

 

    

 

 

   

 

 

      

 

 

 

Total assets

   $ 1,020,594       $ 53,362      $ 118,580         $ 1,192,536   
  

 

 

    

 

 

   

 

 

      

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

            

Current liabilities:

            

Accounts payable, accrued expenses and other current liabilities

   $ 132,258       $ 12,428      $ (12,428   (b)    $ 132,258   

Borrowings under Revolving Credit Facility

     75,000         —          —             75,000   

Contingent consideration

     10,000         —          —             10,000   

Current portion of build-to-suit lease obligation

     235         —          —             235   
  

 

 

    

 

 

   

 

 

      

 

 

 

Total current liabilities

     217,493         12,428        (12,428        217,493   

Contingent consideration

     102,799         11,508        160,434      (e)      274,741   

Deferred tax liability

     —           12,681        (12,681   (b)      —     

Build-to-suit lease obligation, excluding current portion

     16,905         —          —             16,905   

Other non-current liabilities

     11,729         —          —             11,729   
  

 

 

    

 

 

   

 

 

      

 

 

 

Total liabilities

     348,926         36,617        135,325           520,868   

Stockholders’ Equity

            

Preferred stock

     —           —          —             —     

Common stock

     1,636         —          —             1,636   

Additional paid-in capital

     626,340         —               626,340   

Investment in research program

     —           238,489        (238,489   (b)      —     

Retained earnings (accumulated deficit)

     43,692         (221,744     221,744      (b)      43,692   
  

 

 

    

 

 

   

 

 

      

 

 

 

Total stockholders’ equity

     671,668         16,745        (16,745        671,668   
  

 

 

    

 

 

   

 

 

      

 

 

 

Total liabilities and stockholders’ equity

   $ 1,020,594       $ 53,362      $ 118,580         $ 1,192,536   
  

 

 

    

 

 

   

 

 

      

 

 

 

See notes to unaudited pro forma condensed combined financial statements which are an integral part of these financial statements.


MEDIVATION, INC.

UNAUDITED PRO FORMA CONDENSED COMBINED

STATEMENTS OF OPERATIONS

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2015

(in thousands, except per share data)

 

     Medivation, Inc.
(Historical)
    Talazoparib
Research Program
(Historical)
    Pro Forma
Adjustments
    See Note
4
  Pro Forma
Combined
 

Collaboration revenue

   $ 565,510      $ —        $ —          $ 565,510   

Operating Expenses:

          

Research and development expenses

     137,841        59,652        —            197,493   

Selling, general and administrative expenses

     234,456        7,370            241,826   

Change in fair value of contingent consideration

     —          (204     204      (f)     —     
  

 

 

   

 

 

   

 

 

     

 

 

 

Total operating expenses

     372,297        66,818        204          439,319   
  

 

 

   

 

 

   

 

 

     

 

 

 

Income (loss) from operations

     193,213        (66,818     (204       126,191   

Other income (expense), net

          

Loss on extinguishment of Convertible Notes

     (21,087     —          —            (21,087

Interest expense

     (11,995     —          —            (11,995

Other, net

     247        —          —            247   
  

 

 

   

 

 

   

 

 

     

 

 

 

Total other income (expense), net

     (32,835     —          —            (32,835
  

 

 

   

 

 

   

 

 

     

 

 

 

Income (loss) before income tax (expense) benefit

     160,378        (66,818     (204       93,356   

Income tax (expense) benefit

     (58,160     —          23,458      (g)     (34,702
  

 

 

   

 

 

   

 

 

     

 

 

 

Net income (loss)

   $ 102,218      $ (66,818   $ 23,254        $ 58,654   
  

 

 

   

 

 

   

 

 

     

 

 

 

Net income per common share:

          

Basic

   $ 0.64            $ 0.37   

Diluted

   $ 0.62            $ 0.36   

Weighted-average common shares:

          

Basic

     159,198              159,198   

Diluted

     164,454              164,454   

See notes to unaudited pro forma condensed combined financial statements which are an integral part of these financial statements.


MEDIVATION, INC.

UNAUDITED PRO FORMA CONDENSED COMBINED

STATEMENTS OF OPERATIONS

FOR THE YEAR ENDED DECEMBER 31, 2014

(in thousands, except per share data)

 

     Medivation, Inc.
(Historical)
    Talazoparib
Research Program
(Historical)
    Pro Forma
Adjustments
    See Note
4
  Pro Forma
Combined
 

Collaboration revenue

   $ 710,487      $ —        $ —          $ 710,487   

Operating Expenses:

          

Research and development expenses

     189,570        64,083        —            253,653   

Selling, general and administrative expenses

     239,071        6,964        —            246,035   

Change in fair value of contingent consideration

     —          867        (867   (f)     —     
  

 

 

   

 

 

   

 

 

     

 

 

 

Total operating expenses

     428,641        71,914        (867       499,688   
  

 

 

   

 

 

   

 

 

     

 

 

 

Income (loss) from operations

     281,846        (71,914     867          210,799   

Other income (expense), net

          

Interest expense

     (21,690     —          —            (21,690

Other, net

     38        —          —            38   
  

 

 

   

 

 

   

 

 

     

 

 

 

Total other income (expense), net

     (21,652     —          —            (21,652
  

 

 

   

 

 

   

 

 

     

 

 

 

Income (loss) before income tax benefit

     260,194        (71,914     867          189,147   

Income tax benefit

     16,258        —          24,866      (g)     41,124   
  

 

 

   

 

 

   

 

 

     

 

 

 

Net income (loss)

   $ 276,452      $ (71,914   $ 25,733        $ 230,271   
  

 

 

   

 

 

   

 

 

     

 

 

 

Net income per common share:

          

Basic

   $ 1.80            $ 1.50   

Diluted

   $ 1.71          (h)   $ 1.44   

Weighted-average common shares:

          

Basic

     153,859              153,859   

Diluted

     170,001              170,001   

See notes to unaudited pro forma condensed combined financial statements which are an integral part of these financial statements.


MEDIVATION, INC.

NOTES TO THE UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS

(UNAUDITED)

(in thousands)

 

1. Basis of Presentation

On September 15, 2015, Medivation, Inc. (the “Company”) effected a two-for-one stock split of its common stock in the form of a stock dividend. The information of the Company’s common stock (except par value per share), par, and additional paid-in capital as of September 30, 2015 and the information of the net income per common share for the periods presented include the effect of the stock split.

 

2. Accounting Policies

During the preparation of the accompanying unaudited pro forma condensed combined financial statements, the Company was not aware of any material differences between the accounting policies of the Company and the talazoparib research program. Accordingly, the accompanying unaudited pro forma condensed combined financial statements do not assume any material differences in accounting policies between the Company and the talazoparib research program. The Company has not finalized its review of the historical accounting policies of the talazoparib research program. Any differences between the Company’s accounting policies and the talazoparib research program’s historical accounting policies could be significant.

 

3. Purchase Price Allocation

The acquisition of the talazoparib research program is accounted for as a business acquisition using the acquisition method of accounting in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic No. 805, “Business Combinations,” whereby the net assets acquired were recognized based their estimated fair values on the acquisition date. Transaction costs associated with the acquisition of the talazoparib asset were not significant.

In connection with the closing of the transaction, the Company made an upfront cash payment of $410.0 million to BioMarin Pharmaceutical Inc. (“BioMarin”). In addition, BioMarin is entitled to contingent payments totaling up to $160.0 million upon the achievement of defined regulatory and sales-based milestones, and mid-single digit royalties on net sales of products that contain talazoparib during the royalty term specified in the Agreement.

The following table presents the preliminary allocation of the purchase consideration, including the contingent consideration payable, based on fair value:

 

Purchase consideration:

  

Upfront cash payment

   $ 410,000   

Acquisition-date fair value of contingent consideration

     171,942   
  

 

 

 

Total purchase consideration

   $ 581,942   
  

 

 

 

Allocation of the purchase consideration:

  

Assets:

  

Identifiable intangible assets- IPR&D

   $ 573,299   
  

 

 

 

Net identifiable assets acquired

     573,299   

Goodwill

     8,643   
  

 

 

 

Net assets acquired

   $ 581,942   
  

 

 

 

The acquisition-date fair value of the contingent consideration payments totaled $171.9 million and was estimated by applying a probability-based income model using a discounted cash flow analysis for contingent regulatory and royalty payments and a Monte Carlo simulation model for the contingent sales milestone payments. Both models utilize key assumptions that included estimated revenues or completion of certain regulatory and sales milestone targets during the earn-out period, volatility, and estimated discount rates corresponding to the periods of expected payments.


Identifiable intangible assets totaled $573.3 million and consist entirely of in-process research and development (“IPR&D”) for talazoparib. As of the valuation date, the Company determined that talazoparib was the only research and development (“R&D”) project with substance, such that the project had undergone conceptual stages, and research, development, and preproduction had been started for the project. As such, no other intangible assets were identified in the transaction other than talazoparib separate from goodwill. The excess of the preliminary purchase consideration over the fair values assigned to the net assets acquired was $8.6 million, which represents the amount of goodwill resulting from the acquisition.

 

4. Pro Forma Adjustments

The following is a summary of the adjustments included under the heading “Pro Forma Adjustments” in the unaudited pro forma condensed combined financial statements. The fair values of the net assets acquired are based on a preliminary valuation of their fair value and may change when the final valuation is determined. Any such adjustments to the preliminary valuation could be significant.

 

a. Represents a $410.0 million reduction to the Company’s cash and cash equivalents for the upfront cash payment to BioMarin upon closing of the transaction.

 

b. Reflects the elimination of the talazoparib research program’s historical assets, liabilities, and equity, which were not acquired or assumed by the Company in connection with the Agreement and as a result are not directly attributable to the transaction.

 

c. Represents the preliminary estimate of the purchase price allocated to IPR&D for the talazoparib research program totaling $573.3 million and the elimination of the historical intangible assets of the talazoparib research program totaling $35.2 million. The historical talazoparib research program’s statements of operations do not include amortization of the IPR&D related to talazoparib. As of the valuation date, the Company determined that talazoparib was the only R&D project with substance, such that the project had undergone conceptual stages, and research, development, and preproduction had been started for the project. As such, no other intangible assets were identified in the transaction other than talazoparib separate from goodwill. The amount represents the preliminary estimate of the fair value assigned to the incomplete project acquired from BioMarin, which at the time of acquisition, had not yet reached technological feasibility. The fair value assigned to the IPR&D was determined using the “income approach,” which is a valuation technique that provides an estimate of the fair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining useful life. Some of the more significant assumptions used in the income approach from the perspective of a market participant include the estimated net cash flows for each year (including revenues, costs of sales, research and development costs, selling, general, and administrative costs, and working capital/contributory asset charges), the discount rate that measures the risk inherent in each future cash flow stream, the assessment of the asset’s life cycle, and competitive trends impacting the asset and each cash flow stream, as well as other factors.

The amounts are capitalized and accounted for as indefinite-lived long-term assets subject to impairment testing until completion or abandonment of the project. Upon successful completion of the project, the Company will make a determination as to the then useful life of the intangible asset and begin amortization over that period. No amortization of IPR&D is included in the pro forma financial statements.

 

d. Reflects the preliminary estimate of the goodwill totaling $8.6 million resulting from the difference between the purchase price and the fair value of the net assets acquired as a result of the Agreement and the elimination of historical goodwill of the talazoparib research program totaling $16.3 million.

 

e.

Represents the preliminary fair value estimate of contingent consideration associated with the Agreement totaling $171.9 million and the elimination of historical contingent consideration of the talazoparib research program totaling $11.5 million. A portion of the contingent consideration included on the historical talazoparib balance sheet is associated with potential future financial obligations that have been assumed by the Company. These potential future obligations are included in the estimated fair value of the IPR&D described above. The preliminary fair value of the contingent consideration was estimated utilizing a model with key assumptions that included estimated revenues or completion of certain regulatory and sales-based milestones during the earn-out period,


  volatility, and estimated discount rates corresponding to the periods of expected payments. The contingent consideration has been classified as long-term based upon the Company’s estimate of the timing of the potential contingent payments.

 

f. Reflects the elimination of changes in the fair value of contingent consideration reflected in the historical statement of operations of the talazoparib research program.

 

g. Reflects the estimated income tax impact of the talazoparib research program’s research and development expense and general and administrative expense, computed at the Federal statutory tax rate of approximately 35%.

 

h. For the year ended December 31, 2014, the computation of diluted net income per share includes the impact of the Company’s convertible notes. Additional information regarding the computation of diluted net income per common share is included in the Company’s Annual Report on Form 10-K