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8-K - 8-K - Baxalta Incd25585d8k.htm

Exhibit 99.1

BAXALTA INCORPORATED

GAAP Product Category Sales by U.S. and International

Three and Six Months Ended June 30, 2015 and 2014 1

(unaudited)

($ in millions)

The below information presents Baxalta’s product category net sales on a GAAP basis by U.S. and International. Refer to the following page for product category net sales on a pro forma basis.

 

     Q2 2015     Q2 2014     % Growth @ Actual Rates     % Growth @ Constant Rates  
     U.S.     International   Total      U.S.     International   Total      U.S.     International    Total       U.S.     International   Total  
                                                                                 
Hemophilia     $   322      $   350     $   672         $   323      $   397     $   720         0%      (12%)     (7%)         0%        7%     4%   
Inhibitor Therapies       69           114        183              52           132        184         33%      (14%)     (1%)         33%        4%     12%   
Hematology     $   391      $   464     $   855         $   375      $   529     $   904         4%      (12%)     (5%)         4%        6%     6%   
Immunoglobulin Therapies                                      318           104        422         294             99        393         8%        5%     7%          8%      27%     13%   
BioTherapeutics       66             86        152           64             91        155         3%        (5%)     (2%)         3%        3%     3%   
Immunology     $   384      $   190     $   574         $   358      $   190     $   548         7%        0%     5%          7%      16%     10%   
Total Baxalta     $   775      $   654     $1,429         $   733      $   719     $1,452         6%        (9%)     (2%)         6%        9%     7%   
                                                                                 
                       
     YTD 2015     YTD 2014     % Growth @ Actual Rates     % Growth @ Constant Rates  
     U.S.     International   Total      U.S.     International   Total      U.S.     International    Total     U.S.     International   Total  
                                                                                 
Hemophilia     $   627      $   686     $1,313         $   620      $   775     $1,395         1%      (11%)     (6%)         1%        4%     3%   
Inhibitor Therapies        132           217        349              96           240        336         38%      (10%)     4%          38%        6%     15%   
Hematology     $   759      $   903     $1,662         $   716      $1,015     $1,731         6%      (11%)     (4%)         6%        5%     5%   
Immunoglobulin Therapies            646           196        842            601           190        791         7%        3%     6%          7%      22%     11%   
BioTherapeutics        125           161        286            122           137        259         2%      18%     10%          2%      28%     16%   
Immunology     $   771      $   357     $1,128         $   723      $   327     $1,050         7%        9%     7%          7%      24%     12%   
Total Baxalta     $1,530      $1,260     $2,790         $1,439      $1,342     $2,781         6%        (6%)     0%          6%        9%     8%   
                                                                                 

 

1 

Sales schedules presented on pages 1 and 2 are consistent with those included in the company’s Current Report on Form 8-K filed with the Securities and Exchange Commission (SEC) on July 30, 2015.

 

BAXALTA — Page 1


BAXALTA INCORPORATED

Pro Forma Product Category Sales by U.S. and International

Three and Six Months Ended June 30, 2015 and 2014

(unaudited)

($ in millions)

The below information presents Baxalta’s product category net sales on a pro forma basis by U.S. and International. A reconciliation to GAAP net sales and a description of the pro forma adjustment is also included below.

 

     Q2 2015     Q2 2014     % Growth @ Actual Rates     % Growth @ Constant Rates  
     U.S.     International   Total     U.S.     International   Total     U.S.     International   Total     U.S.     International   Total  
                                                                                 
Hemophilia     $   322      $   350     $   672         $   323      $   397     $   720         0%      (12%)     (7%)         0%        7%     4%   
Inhibitor Therapies       69           114        183           52           132        184         33%      (14%)     (1%)         33%        4%     12%   
Hematology     $   391      $   464     $   855         $   375      $   529     $   904         4%      (12%)     (5%)         4%        6%     6%   
Immunoglobulin Therapies     318           104        422         294             99        393         8%        5%     7%          8%      27%     13%   
Pro Forma BioTherapeutics 1           66           126        192           64           128        192         3%        (2%)     0%          3%        5%     4%   
Pro Forma Immunology     $   384      $   230     $   614         $   358      $   227     $   585         7%        1%     5%          7%      15%     10%   
Pro Forma Total Baxalta     $   775      $   694     $1,469         $   733      $   756     $1,489         6%        (8%)     (1%)         6%        9%     7%   
                                                                                 
                                                                 
     YTD 2015     YTD 2014     % Growth @ Actual Rates     % Growth @ Constant Rates  
     U.S.     International   Total      U.S.     International   Total      U.S.     International    Total       U.S.     International   Total  
                                                                                 
Hemophilia     $   627      $   686     $1,313        $   620      $   775     $1,395         1%      (11%)     (6%)         1%        4%     3%   
Inhibitor Therapies        132           217        349             96           240        336         38%      (10%)     4%          38%        6%     15%   
Hematology     $   759      $   903     $1,662        $   716      $1,015     $1,731         6%      (11%)     (4%)         6%        5%     5%   
Immunoglobulin Therapies        646           196        842           601      190        791         7%        3%     6%          7%      22%     11%   
Pro Forma BioTherapeutics 1            125           243        368           122           218        340         2%      11%     8%          2%      18%     13%   
Pro Forma Immunology     $   771      $   439     $1,210         $   723      $   408     $1,131         7%        8%     7%          7%      20%     11%   
Pro Forma Total Baxalta     $1,530      $1,342     $2,872         $1,439      $1,423     $2,862         6%        (6%)     0%          6%        9%     8%   
                                                                                 

 

Pro Forma Net Sales Reconciliations

 

 

  

 

     Q2 2015     Q2 2014     % Growth @ Actual Rates     % Growth @ Constant Rates  
     U.S.     International   Total      U.S.     International   Total     U.S.     International    Total       U.S.     International   Total  
                                                                                 
BioTherapeutics     $     66      $     86     $   152         $     64      $     91     $155         3%        (5%)     (2%)         3%        3%     3%   
Pro forma MSA revenue 1       —             40       40           —             37       37                                            
Pro Forma BioTherapeutics                              $     66      $   126     $   192         $     64      $   128     $192         3%        (2%)     0%          3%        5%     4%   
                                                                                 
                                                                 
     YTD 2015     YTD 2014     % Growth @ Actual Rates     % Growth @ Constant Rates  
     U.S.     International   Total      U.S.     International   Total      U.S.     International    Total       U.S.     International   Total  
                                                                                 
BioTherapeutics     $   125      $   161     $   286         $   122      $   137     $259         2%      18%     10%          2%      28%     16%   
Pro forma MSA revenue 1         —             82       82             —             81       81                                            
Pro Forma BioTherapeutics         $   125      $   243     $   368         $   122      $   218     $340         2%      11%     8%          2%      18%     13%   
                                                                                 

 

1 

In connection with the separation, Baxalta and Baxter entered into a manufacturing and supply agreement whereby Baxalta will manufacture and sell certain products to Baxter. The pro forma net sales figures assume that the manufacturing and supply agreement was in effect in periods prior to the separation. Net sales related to the manufacturing and supply agreement will be reported in the company’s actual net sales figures in periods following the separation.

 

BAXALTA — Page 2


BAXALTA INCORPORATED

Combined Statements of Income A

Three and Six Months Ended June 30, 2015 and 2014

(unaudited)

($ in millions)

 

                                                                                                                 
    Three Months Ended
June 30,
            Six Months Ended
June 30,
        
    2015      2014      Change      2015      2014      Change  

NET SALES

    $  1,429         $  1,452         (2%      $  2,790         $  2,781         0%   

COST OF SALES

    501         599         (16%      1,072         1,158         (7%
                

 

 

GROSS MARGIN

    928         853         9%         1,718         1,623         6%   

 

 

% of Net Sales

    64.9%         58.7%         6.2 pts         61.6%         58.4%         3.2 pts   

SELLING, GENERAL AND ADMINISTRATIVE EXPENSES

    323         242         33%         606         464         31%   

% of Net Sales

    22.6%         16.7%         5.9 pts         21.7%         16.7%         5.0 pts   

RESEARCH AND DEVELOPMENT EXPENSES

    240         166         45%         396         329         20%   

% of Net Sales

    16.8%         11.4%         5.4 pts         14.2%         11.8%         2.4 pts   

NET INTEREST EXPENSE

    3                 N/M         3                 N/M   

OTHER (INCOME) EXPENSE, NET

    (20      30         N/M         (8 )       7         N/M   
                

 

 

PRE-TAX INCOME FROM CONTINUING OPERATIONS

    382         415         (8%      721         823         (12%

 

 

INCOME TAX EXPENSE

    98         97         1%         175         196         (11%

 

 

% of Pre-Tax Income from Continuing Operations

    25.7%         23.4%         2.3 pts         24.3%         23.8%         0.5 pts   
                

 

 

NET INCOME FROM CONTINUING OPERATIONS

    284         318         (11%      546         627         (13%

 

 

(LOSS) INCOME FROM DISCONTINUED OPERATIONS, NET OF TAXB

    (4      52         N/M         6         101         (94%
                

 

 

NET INCOME

    $      280         $     370         (24%      $     552         $     728         (24%

 

 

BASIC EPS FROM CONTINUING OPERATIONS

    $     0.42         $    0.47         (11%      $    0.81         $    0.93         (13%

 

 

DILUTED EPS FROM CONTINUING OPERATIONS

    $     0.42         $    0.47         (11%      $    0.80         $    0.92         (13%

 

 

WEIGHTED-AVERAGE NUMBER OF COMMON SHARES OUTSTANDINGC

                

Basic

    676         676            676         676      

Diluted

    681         681            681         681      

 

 

Pro Forma and Non-GAAP MeasuresD

                

PRO FORMA NET SALES

    $  1,469         $  1,489         (1%      $  2,872         $  2,862         0%   

ADJUSTED PRO FORMA OPERATING INCOME

    $     517         $     492         5%         $     926         $     914         1%   

ADJUSTED PRO FORMA EBITDA

    $     568         $     542         5%         $  1,029         $  1,010         2%   

ADJUSTED PRO FORMA NET INCOME

    $     374         $     361         4%         $     649         $     674         (4%

ADJUSTED PRO FORMA DILUTED EPS

    $    0.55         $    0.53         4%         $    0.95         $    0.99         (4%

 

A 

Combined statements of income presented in accordance with generally accepted accounting principles (GAAP) unless otherwise noted. Refer to the company’s Q2 2015 Form 10-Q filed with the SEC on August 13, 2015 for additional information.

 

B 

Operating results from the company’s vaccines business are classified as discontinued operations for all periods presented.

 

C 

On July 1, 2015 Baxter distributed approximately 544 million shares of Baxalta common stock and retained an additional 132 million shares. The computation of basic weighted-average shares outstanding for both periods presented was calculated using the shares distributed and the shares retained by Baxter on July 1, 2015. The diluted weighted-average number of shares outstanding for the periods presented include the dilutive effect of common share equivalents for employee equity awards outstanding as of July 1, 2015.

 

D 

Refer to pages 4 through 6 for reconciliations of GAAP to pro forma and non-GAAP measures.

 

BAXALTA — Page 3


BAXALTA INCORPORATED

Notes to Combined Statements of Income

Three and Six Months Ended June 30, 2015 and 2014

Reconciliation of GAAP to Pro Forma and Non-GAAP Measures

(unaudited)

($ in millions)

Below are reconciliations of Adjusted Pro Forma Operating Income, Adjusted Pro Forma EBITDA, Adjusted Pro Forma Net Income and Adjusted Pro Forma Diluted Earnings per Share to their most directly comparable GAAP financial measures.

 

                                                                                                                 
    Three Months Ended
June  30,
            Six Months Ended
June  30,
        
    2015      2014      Change      2015      2014      Change  
                
Adjusted Pro Forma Operating Income and Adjusted Pro Forma EBITDA   
   

Pre-tax Income from Continuing Operations - GAAP

    $      382         $      415         (8%      $      721         $      823         (12%
   

Pro forma adjustments1

    (30      (35         (63      (71     
   

Special item adjustments1

    138         79            182         105        
                    

Adjusted Pro Forma Pre-tax Income

    $      490         $      459         7%         $      840         $      857         (2%
   

Remove: Net interest expense

    47         47            94         94        

Remove: Other income, net

    (20      (14         (8      (37     
                    

Adjusted Pro Forma Operating Income

    $      517         $      492         5%         $      926         $      914         1%   

% of Pro Forma Net Sales

    35.2%         33.0%         2.2pts         32.2%         31.9%         0.3pts   
   

Remove: Depreciation expense

    51         50            103         96        
                    

Adjusted Pro Forma EBITDA

    $      568         $      542         5%         $   1,029         $   1,010         2%   

% of Pro Forma Net Sales

    38.7%         36.4%         2.3pts         35.8%         35.3%         0.5pts   
                
Adjusted Pro Forma Net Income   
   

Net Income From Continuing Operations - GAAP

    $      284         $      318         (11%      $      546         $      627         (13%
   

Pro Forma Adjustments

                  
   

Pre-tax pro forma adjustments1

    (30      (35         (63      (71     

Impact of pro forma adjustments on income tax expense

    11         15            24         31        
   

Special Item Adjustments

                  
   

Pre-tax special item adjustments1

    138         79            182         105        

Impact of special item adjustments on income tax expense

    (29      (16         (40      (18     
                    

Adjusted Pro Forma Net Income

    $      374         $      361         4%         $      649         $      674         (4%
                
Adjusted Pro Forma Diluted EPS   
   

Diluted EPS From Continuing Operations - GAAP

    $     0.42         $     0.47         (11%      $     0.80         $     0.92         (13%
   

Pro Forma Adjustments

                  
   

Impact of pro forma adjustments on diluted EPS

    (0.03      (0.03         (0.06      (0.06     
   

Special Item Adjustments

                  
   

Impact of special item adjustments on diluted EPS

    0.16         0.09            0.21         0.13        
                    

Adjusted Pro Forma Diluted EPS

    $     0.55         $     0.53         4%         $     0.95         $     0.99         (4%

 

1 

Refer to pages 5 and 6 for descriptions of pro forma and special item adjustments and the impacted statement of income line items.

 

BAXALTA — Page 4


BAXALTA INCORPORATED

Notes to Combined Statements of Income

Three and Six Months Ended June 30, 2015 and 2014

Reconciliation of GAAP to Pro Forma and Non-GAAP Measures (continued)

(unaudited)

($ in millions)

The company’s pro forma and special item adjustments by statement of income line item are listed below:

 

                                                                                                                 
    Three Months Ended
June 30,
            Six Months Ended
June 30,
        
    2015      2014      Change      2015      2014      Change  
                

Net Sales - GAAP

    $   1,429         $   1,452         (2%      $   2,790         $   2,781         0%   

Pro forma adjustments

                  

Manufacturing and supply arrangements with Baxter1

    40         37                  82         81            

Pro Forma Net Sales

    $   1,469         $   1,489         (1%      $   2,872         $   2,862         0%   
                

Gross Margin - GAAP

    $      928         $      853         9%         $   1,718         $   1,623         6%   

Pro forma adjustments

                  

Depreciation expense4

            (2         (1      (4     

Manufacturing and supply arrangements with Baxter1

    (1      1            (1      1        

Pension expense2

    3         4            8         8        

Pro Forma Gross Margin

    $      930         $      856         9%         $   1,724         $   1,628         6%   

Special item adjustments

                  

Intangible asset amortization expense7

    8         4            16         7        

Separation costs9

    1                    1                

Business optimization items6

            (2                        

Adjusted Pro Forma Gross Margin

    $      939         $      858         9%         $   1,741         $   1,635         6%   

% of Pro Forma Net Sales

    63.9%         57.6%         6.3 pts         60.6%         57.1%         3.5 pts   
                

Selling, General and Administrative Expenses - GAAP

    $      323         $      242         33%         $      606         $      464         31%   

Pro forma adjustments

                  

Depreciation expense4

    1                    2         1        

Supply chain TSA3

    (5      (5         (10      (10     

Pension expense2

    (7      (4         (12      (8     

Pro Forma Selling, General and Administrative Expenses

    $      312         $      233         34%         $      586         $      447         31%   

Special item adjustments

                  

Business optimization items6

    (3      1            (2      1        

Separation costs9

    (34      (1         (70      (1     

Plasma related litigation10

                               10        

Adjusted Pro Forma Selling, General and Administrative Expenses

    $      275         $      233         18%         $      514         $      457         12%   

% of Pro Forma Net Sales

    18.7%         15.6%         3.1 pts         17.9%         16.0%         1.9 pts   
                

Research and Development Expenses - GAAP

    $      240         $      166         45%         $      396         $      329         20%   

Pro forma adjustments

                  

Pension expense2

    (1                 (2      (1     

Pro Forma Research and Development Expenses

    $      239         $      166         44%         $      394         $      328         20%   

Special item adjustments

                  

Separation costs9

    (5                 (12             

Business optimization items6

            2            6         (4     

Upfront and milestone payments to collaboration partners8

    (87      (35         (87      (60     

Adjusted Pro Forma Research and Development Expenses

    $      147         $      133         11%         $      301         $      264         14%   

% of Pro Forma Net Sales

    10.0%         8.9%         1.1 pts         10.5%         9.2%         1.3 pts   
                

Net Interest Expense - GAAP

    3                 N/M         3                 N/M   

Pro forma adjustments

                  

Interest expense5

    44         47            91         94        

Pro Forma Net Interest Expense

    $        47         $        47         0%         $        94         $         94         0%   
                

Other (Income) Expense, Net - GAAP

    $       (20      $        30         N/M         $         (8      $           7         N/M   

Special item adjustments

                  

Change in fair value of contingent payment liabilities11

            (44                 (44     

Adjusted Other Income, Net

    $       (20      $       (14      43%         $         (8      $       (37      N/M   

Refer to page 6 for tickmark explanations

 

 

BAXALTA — Page 5


BAXALTA INCORPORATED

Notes to Combined Statements of Income

Three and Six Months Ended June 30, 2015 and 2014

Reconciliation of GAAP to Pro Forma and Non-GAAP Measures (continued)

(unaudited)

($ in millions)

The company’s pro forma and special item adjustments by statement of income line item are listed below (continued):

 

                                                                                                                 
    Three Months Ended
June 30,
            Six Months Ended
June 30,
        
    2015      2014      Change      2015      2014      Change  
                

Pre-Tax Income - GAAP

    $     382         $     415         (8%      $     721         $    823         (12%

Impact of pro forma adjustments

    (30      (35               (63      (71         

Impact of special item adjustments

    138         79                  182         105            

Adjusted Pro Forma Pre-Tax Income from Continuing Operations

    $     490         $     459         7%         $     840         $    857         (2%
                

Income Tax Expense - GAAP

    $       98         $       97         1%         $     175         $    196         (11%

Impact of pro forma adjustments

    (11      (15               (24      (31         

Impact of special item adjustments

    29         16            40         18        

Adjusted Pro Forma Income Tax Expense

    $     116         $       98         18%         $     191         $    183         4%   

% of Adjusted Pro Forma Pre-tax Income from Continuing Operations

    23.7%         21.4%         2.3 pts         22.7%         21.4%         1.3 pts   

Description of pro forma adjustments:

The pro forma adjustments illustrate the financial impacts of the separation of Baxalta from Baxter International Inc. and the related transactions described below. The pro forma statement of income adjustments give effect to the separation and related transactions described below as if they had occurred as of January 1, 2014. The pro forma adjustments are for informational purposes only and do not purport to represent what Baxalta’s results of operations actually would have been had the separation and related transactions occurred on the dates indicated, or to project Baxalta’s financial performance for any future period.

 

  (1) Reflects the effect of the manufacturing and supply agreement that Baxalta and Baxter entered into in connection with the separation. The net sales adjustment reflects additional sales that Baxalta would have recorded for product manufactured and sold to Baxter. The cost of sales adjustment reflects the impact of costs incurred to manufacture these products as well as incremental costs that Baxalta would have recorded for purchases of other products from Baxter under the manufacturing and supply agreement.

 

  (2) Reflects a reduction in operating expenses related to the impact of net retirement obligations transferred to Baxalta as part of the separation.

 

  (3) Reflects a reduction in selling, general and administrative expenses for the difference in costs to be incurred by Baxalta for certain supply chain services to be provided by Baxter under terms of the transition services agreement.

 

  (4) Reflects a net increase in depreciation expense related to certain assets transferred to Baxalta pursuant to the separation agreement that were not included in the company’s historical financial statements.

 

  (5) Reflects interest expense associated with approximately $5 billion of debt issued by Baxalta in advance of the separation. The pro forma adjustment does not include an estimate of the portion that may have been capitalized.

Description of special item adjustments

 

  (6) The company’s GAAP results were impacted by costs, and favorable adjustments to previously estimated costs, associated with the company’s execution of certain strategies to optimize its organizational structure. The charges and adjustments impacted cost of sales, selling, general and administrative expenses and research and development (R&D) expenses in the periods presented.

 

  (7) The company’s GAAP results included intangible asset amortization expense for each period presented.

 

  (8) The company’s GAAP results included R&D charges associated with upfront payments to collaboration partners and payments to collaboration partners upon the achievement of development milestones.

 

  (9) The company’s GAAP results were impacted by separation costs incurred to prepare Baxalta to operate as an independent, standalone public company.

 

  (10) The company’s GAAP results included a benefit associated with the reversal of a portion of a legal charge following the settlement of class-action litigation associated with pricing of plasma-derived therapies.

 

  (11) The company’s GAAP results included losses resulting from increases in the fair value of contingent payment liabilities associated with previously completed business combinations.

For more information on the company’s use of non-GAAP financial measures in this release, please see the company’s Current Report on Form 8-K filed with the SEC on August 13, 2015.

 

BAXALTA — Page 6