EX-99.1 2 ex99_1.htm EARNINGS PRESS RELEASE OF GENENTECH, INC. DATED JANUARY 15, 2009 ex99_1.htm

 
EXHIBIT 99.1

NEWS RELEASE
       
 
Media Contact:
Geoff Teeter
Caroline Pecquet
(650) 467-6800
(650) 467-6800
       
 
Investor Contact:
Kathee Littrell
Sue Morris
(650) 225-1034
(650) 225-6523
       
 
http://www.gene.com




GENENTECH ANNOUNCES FULL YEAR AND FOURTH QUARTER 2008 RESULTS

SOUTH SAN FRANCISCO, Calif. – January 15, 2009 – Genentech, Inc. (NYSE: DNA) today announced financial results for the full year and fourth quarter of 2008.  Key results for the full year 2008 include:
Ÿ  
U.S. product sales of $9,503 million, an 11 percent increase from $8,540 million in 2007.
Ÿ  
Non-GAAP operating revenue of $13,403 million, a 14 percent increase from $11,718 million in 20071; GAAP operating revenue of $13,418 million, a 14 percent increase from $11,724 million in 2007.
Ÿ  
Non-GAAP net income of $3,643 million, a 16 percent increase from $3,142 million in 20071; GAAP net income of $3,427 million, a 24 percent increase from $2,769 million in 2007.
Ÿ  
Non-GAAP earnings per share of $3.42, a 16 percent increase from $2.94 in 20071; GAAP earnings per share of $3.21, a 24 percent increase from $2.59 in 2007. 
 
"We are pleased that 2008 was another year of solid financial growth for Genentech. In addition, our late-stage and early-stage development efforts progressed well across our focus areas with four sBLA filings submitted for serious diseases in oncology and immunology, and Phase I clinical trials initiated for eight new molecular entities, including in neuroscience," said Arthur D. Levinson, Ph.D., Genentech’s chairman and chief executive officer. "In 2009, we have the potential to receive four FDA approvals and we anticipate filing more than ten regulatory applications for new indications."

The company announced it is currently forecasting full-year 2009 non-GAAP earnings to be in the range of $3.55 to $3.90 per share1, recognizing that there are a large number of business uncertainties that make it a difficult year to forecast.

Other Financial Results
Key results for the fourth quarter of 2008 include:
Ÿ  
U.S. product sales of $2,495 million, a 13 percent increase from $2,199 million in the fourth quarter of 2007.
Ÿ  
Non-GAAP operating revenue of $3,703 million, a 25 percent increase from $2,966 million in the fourth quarter of 20071; GAAP operating revenue of $3,707 million, a 25 percent increase from $2,970 million in the fourth quarter of 2007.
Ÿ  
Non-GAAP net income of $1,014 million, a 38 percent increase from $737 million in the fourth quarter of 20071; GAAP net income of $931 million, a 47 percent increase from $632 million in the fourth quarter of 2007.
Ÿ  
Non-GAAP earnings per share of $0.95, a 38 percent increase from $0.69 in the fourth quarter of 20071; GAAP earnings per share of $0.87, a 47 percent increase from $0.59 in the fourth quarter of 2007.
 
 
 
 
 
Reconciliations between non-GAAP and GAAP earnings per share for the full years 2008 and 2007 and the fourth quarters of 2008 and 2007 are provided in the following table:

   
Non-GAAP Diluted EPS1
 
Employee Stock-Based
Compensation Expense
 
Net Charges related to Redemption, Tanox Acquisition and Special Items2
 
In-process Research and Development Expense Related to Tanox Acquisition
 
Non-Cash Gain on
Tanox Acquisition
 
Reported GAAP
Diluted EPS1
FY 2008
 
$3.42
 
($0.25)
 
$0.04
 
 
 
$3.21
FY 2007
 
$2.94
 
($0.24)
 
($0.10)
 
($0.07)
 
$0.07
 
$2.59
Q4 2008
 
$0.95
 
($0.05)
 
($0.03)
 
 
 
$0.87
Q4 2007
 
$0.69
 
($0.07)
 
($0.03)
 
 
 
$0.59
Note: Amounts may not sum due to rounding.
 
Product Sales and Total Operating Revenue
Information on product sales and total operating revenue for the three months and years ended December 31, 2008 and 2007, are provided in the following table (dollars in millions):

   
Three Months
Ended December 31,
   
Year
Ended December 31,
 
   
2008
   
2007
   
% Change
   
2008
   
2007
   
% Change
 
Avastin® i
  $ 731     $ 603       21 %   $ 2,686     $ 2,296       17 %
Rituxan®
    677       596       14       2,587       2,285       13  
Herceptin®
    336       327       3       1,382       1,287       7  
Lucentis®
    236       197       20       875       815       7  
Xolair®
    135       120       13       517       472       10  
Tarceva®
    118       112       5       457       417       10  
Nutropin® Products
    90       93       (3 )     358       371       (4 )
Thrombolytics
    74       66       12       275       268       3  
Pulmozyme®
    72       58       24       257       223       15  
Raptiva®
    25       28       (11 )     108       107       1  
Total U.S. product sales ii
  $ 2,495     $ 2,199       13 %   $ 9,503     $ 8,540       11 %
                                                 
Net product sales to collaborators
    486       150       224       1,028       903       14  
Total product sales ii
  $ 2,981     $ 2,349       27 %   $ 10,531     $ 9,443       12 %
                                                 
Non-GAAP royalty revenue iii
    603       554       9       2,524       1,978       28  
Contract revenue
    119       63       89       348       297       17  
Non-GAAP total operating revenue 1
  $ 3,703     $ 2,966       25 %   $ 13,403     $ 11,718       14 %
_________________________
i
Fourth-quarter and full-year 2008 Avastin U.S. product sales results include net deferrals of approximately $2 million and $5 million, respectively, in conjunction with the company’s Avastin Patient Assistance Program launched in February 2007.
ii
Amounts may not sum due to rounding.
iii
GAAP royalty revenue of $607 million in the fourth quarter of 2008 increased 9 percent from $558 million in the fourth quarter of 2007; GAAP royalty revenue of $2,539 for the full year 2008 increased 28 percent from $1,984 million in 2007.
 
 
 
 
 
Total Costs and Expenses
Information on costs and expenses including cost of sales (COS), research and development (R&D) and marketing, general and administrative (MG&A) expenses for the three months and years ended December 31, 2008 and 2007, are provided in the following tables (dollars in millions)3:

   
Three Months
Ended December 31,
   
Year
Ended December 31,
 
   
2008
   
2007
   
% Change
   
2008
   
2007
   
% Change
 
non-GAAP3
                                   
COS
  $ 483     $ 322       50 %   $ 1,662     $ 1,500       11 %
R&D
    724       579       25       2,648       2,293       15  
MG&A
    675       650       4       2,211       2,077       6  
                                                 
GAAP
                                               
COS
    503       344       46       1,744       1,571       11  
R&D
    757       618       22       2,800       2,446       14  
MG&A
    718       692       4       2,405       2,256       7  

   
Three Months
Ended December 31,
   
Year
Ended December 31,
 
   
2008
   
2007
   
2008
   
2007
 
non-GAAP3
                       
COS as a % of product sales
    16 %     14 %     16 %     16 %
R&D as a % of operating revenues
    20 %     20 %     20 %     20 %
MG&A as a % of operating revenues
    18 %     22 %     16 %     18 %
                                 
GAAP
                               
COS as a % of product sales
    17 %     15 %     17 %     17 %
R&D as a % of operating revenues
    20 %     21 %     21 %     21 %
MG&A as a % of operating revenues
    19 %     23 %     18 %     19 %

Clinical Development
In the fourth quarter of 2008, Genentech completed enrollment in three Phase III Lucentis® (ranibizumab injection) trials, including for the treatment of retinal vein occlusion (BRAVO and CRUISE studies) and diabetic macular edema (RISE study).

In December of 2008, Genentech submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Xolair® (Omalizumab) to extend its current asthma indication to the pediatric setting for children 6 and older.

The company also received dates for Prescription Drug User Fee Act (PDUFA) reviews of its two sBLA submissions for Avastin® (bevacizumab) in relapsed glioblastoma (May 5, 2009) and Avastin in combination with interferon alfa-2a therapy for patients with first-line metastatic renal cell carcinoma (August 1, 2009).

Webcast
Members of Genentech’s management team will be participating in a conference call to discuss the company’s financial and other business results on Thursday, January 15, 2009, at 1:45 p.m. Pacific Time (PT).  Live audio of the conference call will be broadcast simultaneously over the internet and may be accessed on Genentech’s web site at http://www.gene.com. The webcast and any corresponding materials will be archived and available for replay until 5:00 p.m. PT on February 5, 2009.

A telephonic audio replay of the webcast will be available beginning at 4:45 p.m. PT on January 15, 2009 through 4:45 p.m. PT on January 22, 2009. Access numbers for this replay are: 1-800-642-1687 (U.S./Canada) and 1-706-645-9291 (international); conference ID number is 75928763.

About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with significant unmet medical needs.  The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.

About Genentech’s Commitment to Patient Access
Genentech is committed to patients having access to our therapies. Through its Genentech Access Solutions program, the company provides patients and healthcare providers with coverage and reimbursement support, patient assistance and informational resources. Patient assistance support is for those eligible patients in the United States who do not have insurance coverage or who cannot afford their out-of-pocket co-pay costs. Since 1985, when its first product was approved, Genentech has donated approximately $1.3 billion in free medicine to uninsured patients through the Genentech® Access to Care Foundation (GATCF) and other product donation programs. Since 2005, Genentech has also donated approximately $250 million to various independent, non-profit organizations that provide financial assistance to eligible patients who cannot access needed medical treatment due to co-pay costs.
 
For information on Genentech’s latest business and product development events please refer to http://www.gene.com/gene/news/press-releases/index.jsp.

This press release contains forward-looking statements regarding submitting more than ten regulatory applications, the potential to receive four FDA approvals, and expected growth in non-GAAP earnings per share for 2009.  Such statements are predictions and involve risks and uncertainties such that actual results may differ materially. Such risks and uncertainties include, but are not limited to, the need for additional data, data analysis or clinical studies; the results of clinical trials; BLA preparation and decision making; FDA actions or delays; failure to obtain or maintain FDA approval; difficulty in obtaining materials from suppliers; unexpected safety, efficacy, manufacturing or distribution issues for Genentech or its contract/collaborator manufacturers; product withdrawals; competition; efficacy data concerning any Genentech product which shows or is perceived to show similar or improved treatment benefit at a lower dose or shorter duration of therapy; pricing decisions by Genentech or its competitors; Genentech’s ability to protect its proprietary rights; the outcome of, and expenses associated with, litigation or legal settlements; cost of sales, other expenses and indebtedness; variations in collaborator sales and expenses; fluctuations in contract revenue and royalties; actions by Roche that are adverse to the interests of Genentech; the outcome of, or developments concerning, Roche’s proposal to acquire Genentech’s outstanding shares; decreases in third party reimbursement rates; the ability of wholesalers to effectively distribute Genentech’s products; and changes in accounting or tax laws or the application or interpretation of such laws. Please also refer to the risk factors identified in Genentech’s periodic reports filed with the Securities and Exchange Commission. Genentech disclaims, and does not undertake, any obligation to update or revise forward-looking statements in this press release.

_________________________
1
Genentech’s non-GAAP operating revenue and royalty revenue exclude recognition of deferred royalty revenue associated with the acquisition of Tanox, Inc. of $4 million for both the fourth quarters of 2008 and 2007, $15 million for the full year 2008, and $6 million for the full year 2007. Genentech’s non-GAAP net income and non-GAAP earnings per share exclude the after-tax impact of certain items associated with the acquisition of Tanox (including recurring recognition of deferred royalty revenue, recurring amortization of intangible assets, in-process research and development expenses [Q3 2007 only], a gain pursuant to Emerging Issues Task Force Issue No. 04-1 [Q3 2007 only], and asset impairment charges [Q3 2008 only]); recurring charges related to the 1999 redemption of Genentech’s stock by Roche Holdings, Inc.; litigation-related and similar special items (in 2008, amount includes the net settlement related to the City of Hope (COH) trial judgment and additional costs accrued based on the status of negotiations between the parties on amounts owed for periods subsequent to the original court judgment rendered in 2002); employee stock-based compensation expense; and certain expenses incurred by the company on behalf of the Special Committee in connection with its review of the Roche Proposal, as well as legal costs incurred in defense of the Special Committee and/or its individual members in shareholder lawsuits filed in connection with the Roche Proposal. The differences in non-GAAP and GAAP amounts are reconciled in the accompanying tables and on http://www.gene.com.
 
2
Full-year 2008 results include a net favorable adjustment of $0.16 per share related to the COH contract dispute and litigation settlement, offset by intangibles amortization related to the 1999 redemption of Genentech’s stock by Roche and the 2007 acquisition of Tanox, Roche Proposal-related fees incurred on behalf of the Special Committee, and other items related to the acquisition of Tanox, including recognition of deferred royalty revenue and asset impairment charges, totaling $0.12 per share.  Full-year 2007 results include accrued interest and bond costs related to the COH trial judgment, intangibles amortization related to the 1999 redemption of Genentech’s stock by Roche and the 2007 acquisition of Tanox, partially offset by recognition of deferred royalty revenue related to the acquisition of Tanox.
 
3
Genentech’s full-year 2008 non-GAAP reported COS, R&D and MG&A expenses exclude the effects of employee stock-based compensation expense of $82 million, $152 million, and $165 million, respectively, and MG&A expense also excludes asset impairment charges of $15 million related to the acquisition of Tanox and charges of $14 million associated with supporting the Special Committee in connection with the Roche Proposal. Full-year 2007 non-GAAP reported COS, R&D and MG&A expenses exclude the effects of employee stock-based compensation expense of $71 million, $153 million, and $179 million, respectively. Genentech’s fourth quarter 2008 non-GAAP reported COS, R&D and MG&A expenses exclude the effects of employee stock-based compensation expense of $20 million, $33 million, and $35 million, respectively, and MG&A expense also excludes charges of $8 million associated with supporting the Special Committee in connection with the Roche Proposal. Fourth quarter 2007 non-GAAP reported COS, R&D and MG&A expenses exclude the effects of employee stock-based compensation expense of $22 million, $39 million, and $42 million, respectively. The differences in non-GAAP and GAAP amounts are reconciled in the accompanying tables and on http://www.gene.com.

 
###
 
 

 
CONSOLIDATED STATEMENTS OF INCOME
(In millions, except per share amounts)
(Unaudited)

   
Three Months
   
Year
 
   
Ended December 31,
   
Ended December 31,
 
   
2008
   
2007
   
2008
   
2007
 
Revenues:
                       
Product sales
  $ 2,981     $ 2,349     $ 10,531     $ 9,443  
Royalties
    607       558       2,539       1,984  
Contract revenue
    119       63       348       297  
      Total operating revenues
    3,707       2,970       13,418       11,724  
                                 
Costs and expenses:
                               
Cost of sales
    503       344       1,744       1,571  
Research and development
    757       618       2,800       2,446  
Marketing, general and administrative
    718       692       2,405       2,256  
Collaboration profit sharing
    322       275       1,228       1,080  
Write-off of in-process research and development related to acquisition(1)
    -       -       -       77  
Gain on acquisition(1)
    -       -       -       (121 )
Recurring amortization charges related to redemption and acquisition(2)
    43       43       172       132  
Special items: litigation-related
    -       14       (260 )     54  
      Total costs and expenses
    2,343       1,986       8,089       7,495  
                                 
Operating income
    1,364       984       5,329       4,229  
                                 
Other income (expense):
                               
Interest and other income, net(3)
    51       40       184       273  
Interest expense
    (25 )     (22 )     (82 )     (76 )
      Total other income, net
    26       18       102       197  
                                 
Income before taxes
    1,390       1,002       5,431       4,426  
Income tax provision
    459       370       2,004       1,657  
Net income
  $ 931     $ 632     $ 3,427     $ 2,769  
                                 
Earnings per share:
                               
Basic
  $ 0.88     $ 0.60     $ 3.25     $ 2.63  
Diluted
  $ 0.87     $ 0.59     $ 3.21     $ 2.59  
                                 
Weighted average shares used to compute earnings per share:
                               
Basic
    1,052       1,053       1,053       1,053  
Diluted
    1,065       1,068       1,067       1,069  
_________________________
(1)
Represents non-recurring items related to our 2007 acquisition of Tanox, Inc.
(2)
Represents the amortization of intangible assets related to the 1999 redemption of our common stock by Roche Holdings, Inc. and our 2007 acquisition of Tanox, Inc.
(3)
"Interest and other income, net" includes interest income, realized gains and losses from the sale of debt and equity securities, write-downs for other-than-temporary impairments in the fair value of certain debt and equity securities and mark-to-market valuation adjustments for various securities. For further detail, refer to our web site at www.gene.com.
 

 
GENENTECH, INC.
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME
(In millions, except per share amounts)
(Unaudited)

   
Three Months
   
Year
 
   
Ended December 31,
   
Ended December 31,
 
   
2008
   
2007
   
2008
   
2007
 
GAAP net income
  $ 931     $ 632     $ 3,427     $ 2,769  
Royalty revenue(1)
    (4 )     (4 )     (15 )     (6 )
Employee stock-based compensation expense under FAS 123R included in the following operating expenses:
                               
Cost of sales
    20       22       82       71  
Research and development
    33       39       152       153  
Marketing, general and administrative
    35       42       165       179  
Asset impairment charges(2)
    -       -       15       -  
Roche Proposal-related fees incurred on behalf of the Special Committee(3)
    8       -       14       -  
Write-off of in-process research and development related to acquisition(4)
    -       -       -       77  
Gain on acquisition(4)
    -       -       -       (121 )
Recurring amortization charges related to redemption and acquisition(5)
    43       43       172       132  
Special items: litigation-related(6)
    -       14       (260 )     54  
Income tax effect(7)
    (52 )     (51 )     (109 )     (166 )
Non-GAAP net income
  $ 1,014     $ 737     $ 3,643     $ 3,142  
                                 
Non-GAAP earnings per share:
                               
Diluted
  $ 0.95     $ 0.69     $ 3.42     $ 2.94  
                                 
Non-GAAP weighted average shares used to compute earnings per share(8):
                               
Diluted
    1,063       1,066       1,065       1,068  
_________________________
(1)
Represents recognition of deferred royalty revenue related to our 2007 acquisition of Tanox, Inc.
(2)
Represents asset impairment charges related to our 2007 acquisition of Tanox, Inc. recorded as marketing, general and administrative expense in the third quarter of 2008.
(3)
Represents costs incurred by the company on behalf of the Special Committee in connection with its review of the Roche Proposal, as well as legal costs incurred in defense of the Special Committee and/or its individual members in shareholder lawsuits filed in connection with the Roche Proposal.
(4)
Represents non-recurring items related to our 2007 acquisition of Tanox, Inc.
(5)
Represents the amortization of intangible assets related to the 1999 redemption of our common stock by Roche Holdings, Inc. and our 2007 acquisition of Tanox, Inc.
(6)
Includes accrued interest and bond costs in the fourth quarter and full year of 2007, and the net settlement in the full year of 2008 related to the City of Hope trial judgment. Amount for the full year of 2008 also includes additional costs accrued related to the City of Hope contract dispute based on the status of negotiations between the parties on amounts owed for periods subsequent to the original court judgment rendered in 2002.
(7)
Reflects the income tax effects of excluding employee stock-based compensation expense under FAS 123R, recurring charges related to the redemption of our common stock, litigation-related special items, items related to our acquisition of Tanox, Inc. and items related to the Roche Proposal.
(8)
Weighted average shares used to compute non-GAAP diluted earnings per share were computed exclusive of the methodology used to determine dilutive securities under FAS 123R.
                 
Reconciliation of 2009 GAAP and Non-GAAP EPS Estimates
       
Our 2009 non-GAAP EPS estimate excludes the effects of:  (i) recurring amortization charges related to the 1999 redemption of our common stock by Roche Holdings, Inc. and our 2007 acquisition of Tanox, Inc., which the company forecasts to be approximately $123 million on a pretax basis in 2009, (ii) items related to our acquisition of Tanox, Inc., including recognition of deferred royalty revenue which the company forecasts to be approximately $15 million on a pretax basis in 2009, (iii) income tax effect on recurring charges related to the redemption of our common stock and our acquisition of Tanox, Inc. and recognition of deferred royalty revenue which the company forecasts to be approximately $42 million in 2009, (iv) employee stock-based compensation expense, which the company forecasts to be in the range of $0.20 to $0.22 per share for 2009 on an after-tax basis, and (v) after tax costs incurred by the company on behalf of the Special Committee in connection with its review of the Roche Proposal, as well as legal costs incurred in defense of the Special Committee and/or its individual members in shareholder lawsuits filed in connection with the Roche Proposal, which the company cannot reasonably estimate for 2009 due to the uncertainty of the outcome of the Roche Proposal. Our 2009 GAAP EPS would include these items listed above as well as any other potential special charges related to existing or future litigation or its resolution, or changes in or adoption of accounting principles, all of which may be significant.
                 
The statements regarding the amounts relating to the 1999 Roche redemption of our common stock, Tanox, Inc. acquisition, litigation-related and similar special items, and employee stock-based compensation expense, are forward-looking and such statements are predictions and involve risks and uncertainties such that actual results may differ materially. The amounts identified above could be affected by a number of factors, including greater than expected litigation-related and similar costs, changes in or adoption of accounting principles, changes in tax rates, the number of options granted to employees, and our stock price and certain valuation assumptions concerning our stock. We disclaim, and do not undertake, any obligation to update or revise any of these forward-looking statements. Please also refer to the risk factors identified in Genentech's periodic reports filed with the Securities and Exchange Commission.
 

 
GENENTECH, INC.
SELECTED CONSOLIDATED FINANCIAL DATA
(In millions)
(Unaudited)

   
December 31,
   
December 31,
 
   
2008
   
2007
 
Selected consolidated balance sheet data:
           
Cash, cash equivalents and short-term investments
  $ 6,198     $ 3,975  
Accounts receivable - product sales, net
    1,039       847  
Accounts receivable - royalties, net
    680       620  
Accounts receivable - other, net
    222       299  
Inventories
    1,299       1,493  
Long-term marketable debt and equity securities
    3,347       2,090  
Property, plant and equipment, net
    5,404       4,986  
Goodwill
    1,590       1,577  
Other intangible assets
    1,008       1,168  
Other long-term assets
    365       366  
Total assets
    21,787       18,940  
Commercial paper
    500       599  
Total current liabilities
    3,095       3,918  
Long-term debt(1)
    2,329       2,402  
Total liabilities
    6,116       7,035  
Total stockholders' equity
    15,671       11,905  

   
Year Ended December 31,
 
   
2008
   
2007
 
Selected consolidated cash flow data:
           
Capital expenditures(1)
  $ 751     $ 977  
                 
Total GAAP depreciation and amortization expense
    592       492  
Less: redemption and acquisition related amortization expense(2)
    (172 )     (132 )
Non-GAAP depreciation and amortization expense
  $ 420     $ 360  
_________________________
(1)
Capital expenditures exclude approximately $117 million at December 31, 2008 and $203 million at December 31, 2007 in capitalized costs related to our accounting for construction projects for which we are considered to be the owner during the construction period.  We have recognized related amounts as a construction financing obligation in long-term debt. The balances in long-term debt related to the construction financing obligation are $306 million at December 31, 2008 and $399 million at December 31, 2007.
(2)
Represents the amortization of intangible assets related to the 1999 redemption of our common stock by Roche Holdings, Inc. and our 2007 acquisition of Tanox, Inc.