Wednesday, Apr 11, 2007

Genentech Announces First Quarter 2007 Results

Total Revenues Increase 43 Percent Over Q1 2006

South San Francisco, Calif. -- April 11, 2007 --

Genentech, Inc. (NYSE: DNA) today announced financial results for the first quarter of 2007. Key results for the first quarter of 2007 include:
  • U.S. product sales of $2,037 million, a 30 percent increase over U.S. product sales of $1,569 million in the first quarter of 2006.
  • Operating revenues of $2,843 million, a 43 percent increase over operating revenues of $1,986 million in the first quarter of 2006.
  • Non-GAAP net income increase of 61 percent to $792 million from $491 million in the first quarter of 20061; GAAP net income increase of 68 percent to $706 million from $421 million reported for the first quarter of 2006.
  • Non-GAAP earnings per share increase of 61 percent to $0.74 per share from $0.46 per share in the first quarter of 20061; GAAP earnings per share increase of 69 percent to $0.66 per share from $0.39 per share reported for the first quarter of 2006.

A reconciliation between non-GAAP and GAAP earnings per share for the first quarters of 2007 and 2006 is provided in the following table:

  Non-GAAP Diluted EPS Employee Stock-Based Compensation  Expense Roche Redemption and Special Items Reported GAAP Diluted EPS

Q1 2007

$0.74 ($0.06) ($0.02) $0.66

Q1 2006

$0.46 ($0.04) ($0.02) $0.39

Note: Amounts may not sum due to rounding.

The company continues to expect approximately 25 to 30 percent growth in non-GAAP earnings per share for the full year 20071, relative to 2006.

Product Sales
Product sales for the three months ended March 31, 2007 are provided in the following table (dollars in millions).

 

Three months
Ended March 31,

 

  2007 2006 % Change
Net U.S. product sales
Avastin® * $533 $398 34%
Rituxan® 535 477 12
Herceptin® 311 290 7
LUCENTIS® 211 -- --
Xolair® 111 95 17
Tarceva® 102 93 10
Nutropin® Products 91 87 5
Thrombolytics 68 59 15
Pulmozyme® 52 49 6
Raptiva® 24 21 14
     
Total U.S. product sales ** 2,037 1,569 30
     
Net product
sales to collaborators
292 75 289
Total product sales ** $2,329 $1,644 42

*First quarter 2007 Avastin U.S. product sales include a net deferral of approximately $3 million in conjunction with the company's Avastin Patient Assistance Program which was launched in February 2007.

**Amounts may not sum due to rounding.

Total Costs and Expenses
Information on costs and expenses for the three months ended March 31, 2007, is provided in the accompanying tables. Key cost and expense highlights include the following:

  • Cost of sales (COS), on a non-GAAP basis, increased 44 percent to $376 million, from $262 million in the first quarter of 20062. Non-GAAP COS expenses as a percentage of product sales were 16 percent, comparable to 16 percent for the first quarter of 2006. On a GAAP basis, COS expenses, including employee stock-based compensation expense for the first time, increased 50 percent to $392 million, from $262 million in the first quarter of 2006. GAAP COS expenses for the first quarter of 2007 were 17 percent of product sales, compared to 16 percent in the first quarter of 2006.
  • Research and development (R&D) expenses, on a non-GAAP basis, increased 68 percent to $572 million, from $341 million in the first quarter of 20062. Non-GAAP R&D expenses as a percentage of operating revenues were 20 percent, compared to 17 percent for the first quarter of 2006. On a GAAP basis, R&D expenses increased 63 percent to $610 million, from $374 million in the first quarter of 2006. GAAP R&D expenses for the first quarter of 2007 were 21 percent of operating revenues, compared to 19 percent in the first quarter of 2006.
  • Marketing, general and administrative (MG&A) expenses, on a non-GAAP basis, increased 11 percent to $445 million, from $400 million in the first quarter of 20062.Non-GAAP MG&A expenses as a percentage of operating revenues were 16 percent, compared to 20 percent in the first quarter of 2006. On a GAAP basis, MG&A expenses increased 11 percent to $491 million, from $441 million in the first quarter of 2006. GAAP MG&A expenses for the first quarter of 2007 were 17 percent of operating revenues, compared to 22 percent in the first quarter of 2006.

Clinical Development
Genentech announced that it and its collaborator Biogen Idec, Inc. successfully submitted to the U.S. Food and Drug Administration (FDA) during the first quarter of 2007 a supplemental Biologics License Application (sBLA) seeking to expand the Rituxan® (Rituximab) label to include inhibition of progression of structural damage in patients with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to previous treatment with one or more tumor necrosis factor (TNF) antagonist therapies. Genentech also completed enrollment in a Phase II/III trial of Rituxan in systemic lupus erythematosus, EXPLORER, and a Phase II study of Avastin® (bevacizumab) in glioblastoma multiforme. The company initiated enrollment in four Phase II Avastin studies in extensive small cell lung cancer, in metastatic melanoma, and in combination with sunitinib malate in both non-small cell lung cancer and metastatic breast cancer. Additionally, the company made Phase II "go" decisions for two of its apoptosis oncology molecules - Apomab and Apo2L/TRAIL. As previously announced, Genentech also made a "go" decision for a Phase III study of Omnitarg™ (pertuzumab), Herceptin® (Trastuzumab) and Taxotere versus Herceptin and Taxotere for patients with HER2-positive first-line metastatic breast cancer.

Webcast
Genentech will be offering a live webcast of a discussion by Genentech management of the earnings and other business results on Wednesday, April 11, 2007, at 2:15 p.m. Pacific Time (PT). The live webcast may be accessed on Genentech's website at http://www.gene.com. This webcast will be available via the website until 5:00 p.m. PT on May 2, 2007. A telephonic audio replay of the webcast will be available beginning at 5:15 p.m. PT on April 11, 2007 through 5:15 p.m. PT on April 18, 2007. Access numbers for this replay are: 1-888-203-1112 (U.S./Canada) and 1-719-457-0820 (international); conference ID number is 8427457.

About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. 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 eligible patients having access to our therapies. For those eligible patients treated for approved indications in the United States who do not have insurance or who cannot afford their out-of-pocket co-pay costs, Genentech has several support programs. Since 1985, Genentech has donated free product to uninsured patients and those deemed uninsured due to payor denial through its Genentech® Access to Care Foundation (GATCF) and the Genentech Endowment for Cystic Fibrosis. In 2006 alone, GATCF supported over 14,000 patients by providing approximately $205 million of free product. Since 2005, Genentech has donated approximately $70 million to various independent public charities that provide financial assistance to eligible patients who cannot access needed medical treatment due to co-pay costs. Through its Single Point of Contact (SPOC) program, Genentech provides patients with assistance and information on a broad array of reimbursement services and support.

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 a forward-looking statement regarding growth in non-GAAP earnings per share (EPS) for 2007. Such statement is a prediction and involves risks and uncertainties such that actual results may differ materially. Among other factors, growth in non-GAAP EPS could be affected by a number of factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses, BLA preparation or decision making, need for additional clinical studies, FDA actions or delays, failure to obtain or maintain FDA approval, competition, pricing, reimbursement, intellectual property or contract rights, the ability to supply product, product withdrawals, new product approvals and launches, achieving sales revenue consistent with internal forecasts, costs of sales, R&D or MG&A expenses, unanticipated expenses such as litigation or legal settlement expenses or equity securities writedowns, stock-based compensation expense, contract revenues and royalties, fluctuations in tax and interest rates, and changes in accounting or tax laws or the interpretation of such laws. Please also refer to Genentech's periodic reports filed with the Securities and Exchange Commission. Genentech disclaims, and does not undertake, any obligation to update or revise the forward-looking statement in this press release.

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1 Genentech's non-GAAP net income and non-GAAP earnings per share exclude the after-tax impact of recurring charges related to the 1999 redemption of Genentech's stock by Roche Holdings, Inc., litigation-related special items and employee stock-based compensation expense associated with Genentech's adoption of FAS 123R on January 1, 2006. Note that Genentech's cumulative effect of a change in accounting principle related to sabbatical leave associated with the adoption of Emerging Issues Task Force Issue No. 06-2 on January 1, 2007, which was $26 million, net of tax, was recognized as an adjustment to retained earnings and not expensed as previously communicated. The differences in non-GAAP and GAAP numbers are reconciled in the accompanying tables and on http://www.gene.com.

2 Genentech's non-GAAP reported COS, R&D and MG&A expenses exclude the effects of employee stock-based compensation expense associated with Genentech's adoption of FAS 123R on January 1, 2006. Stock-based compensation expense was recognized in COS for the first time in the first quarter of 2007 as the company capitalized employee stock-based compensation into inventory produced in 2006 and is beginning to sell those products in 2007. The differences in non-GAAP and GAAP numbers are reconciled in the accompanying tables and on http://www.gene.com.

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