-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VzGiKN7PpwHQbM6G2aCXB8XC2L0qLCHJ+gMs5C0UJkvLIGKD/k74/QhPhcO6AxNt KQwfZCtWBCCGkpvr4+si3w== 0000318771-05-000009.txt : 20051011 0000318771-05-000009.hdr.sgml : 20051010 20051011061613 ACCESSION NUMBER: 0000318771-05-000009 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20051010 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051011 DATE AS OF CHANGE: 20051011 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENENTECH INC CENTRAL INDEX KEY: 0000318771 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 942347624 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09813 FILM NUMBER: 051130666 BUSINESS ADDRESS: STREET 1: 1 DNA WAY CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650-225-1000 MAIL ADDRESS: STREET 1: 1 DNA WAY STREET 2: . CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 dna-8k_q305.htm GENENTECH, INC. - FORM 8-K (OCTOBER 10, 2005) Genentech, Inc. - Form 8-K (Period ended October 10, 2005)

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 10, 2005

 

GENENTECH, INC.
(Exact name of Registrant as specified in its charter)

 

Delaware
(State or other jurisdiction
of incorporation)

1-9813
(Commission
File Number)

94-2347624
(I.R.S. Employer
Identification No.)

 

1 DNA Way
South San Francisco, California 94080-4990
(Address of principal executive offices and Zip Code)

Registrant's telephone number, including area code: (650) 225-1000

Not Applicable
(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ]

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 


 

ITEM 2.02.

RESULTS OF OPERATIONS AND FINANCIAL CONDITION

On October 10, 2005, Genentech, Inc., a Delaware corporation, issued a press release announcing earnings for the quarter ended September 30, 2005. A copy of the earnings press release is furnished as Exhibit 99.1 to this report.

The attached press release contains both GAAP and non-GAAP financial measures. The non-GAAP financial measures included are net income and earnings per share (or EPS). These non-GAAP financial measures exclude recurring charges related to the redemption of our callable putable common stock on June 30, 1999 (the "Redemption") and litigation-related special items, and their related tax effects. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures prepared in accordance with GAAP.

The press release includes non-GAAP financial measures because our management uses this information to monitor and evaluate Genentech's operating results and trends on an on-going basis. Our management believes the non-GAAP information is also useful for investors because the amounts relating to the Redemption and push-down accounting and the litigation-related special items that are excluded were the result of transactions that are unusual due to their nature, size or infrequency. Consequently, excluding those items from our operating results provides users of the financial statements an important insight into our operating results and related trends that affect our business. In addition, our management uses non-GAAP financial information and measures internally for operating, budgeting and financial planning purposes.

 

ITEM 8.01.

OTHER EVENTS

A copy of our consolidated statements of income data for the three and nine months ended September 30, 2005, and consolidated balance sheets data at September 30, 2005 prepared in accordance with GAAP is filed as Exhibit 99.2 to this report.

 

ITEM 9.01.

FINANCIAL STATEMENTS AND EXHIBITS

(c)

 

Exhibits.

Exhibit No.

 

99.1

 

Earnings Press Release of Genentech, Inc. dated October 10, 2005.

99.2

 

Consolidated Statements of Income and Balance Sheets Data

 

- 2 -


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


     

GENENTECH, INC.

 

Date:

  October 10, 2005

 

/s/ARTHUR D. LEVINSON

     

Arthur D. Levinson, Ph.D.
Chairman and Chief Executive Officer

       
       

Date:

  October 10, 2005

 

/s/DAVID A. EBERSMAN

     

David A. Ebersman
Senior Vice President and
Chief Financial Officer

       
       

Date:

  October 10, 2005

 

/s/JOHN M. WHITING

     

John M. Whiting
Vice President, Controller and
Chief Accounting Officer

 

- 3 -


 

EXHIBIT INDEX

Exhibit No.

Description

   

99.1

 

Earnings Press Release of Genentech, Inc. dated October 10, 2005.

99.2

 

Consolidated Statements of Income and Balance Sheets Data

 

- 4 -


 

EX-99.1 2 dna-8kex99_1.htm GENENTECH, INC. - EXHIBIT 99.1 Genentech Inc. - Exhibit 99.1

EXHIBIT 99.1

NEWS RELEASE

       
 

Media Contact:

Debra Charlesworth
Caroline Pecquet

(650) 225-2742
(650) 467-7078

 

Investor Contact:

Kathee Littrell
Sue Morris

(650) 225-1034
(650) 225-6523

 

http://www.gene.com

 

GENENTECH ANNOUNCES THIRD QUARTER 2005 RESULTS

-- Quarterly Non-GAAP EPS Increases 46 Percent to $0.35 --

-- Quarterly Oncology U.S. Product Sales Top $1 Billion
for First Time in Company History --

SOUTH SAN FRANCISCO, Calif. -- October 10, 2005 -- Genentech, Inc. (NYSE: DNA) today announced financial results for the third quarter of 2005. Key results for the third quarter of 2005 included:

  • Non-GAAP earnings per share increase of 46 percent to $0.35 per share from $0.24 per share in the third quarter of 2004; GAAP earnings per share increase of 57 percent to $0.33 per share from $0.21 per share in the third quarter of 2004;
  • Total product sales of $1,451.0 million, a 44 percent increase over product sales of $1,005.5 million in the third quarter of 2004;
  • Operating revenues of $1,751.8 million, a 46 percent increase over operating revenues of $1,202.6 million in the third quarter of 2004;
  • Non-GAAP net income increase of 48 percent to $383.8 million from $259.6 million in the third quarter of 2004; GAAP net income increase of 56 percent to $359.4 million from $230.9 million in the third quarter of 2004.

"Genentech's first nine months of 2005 have been exceptional, with a string of five consecutive positive Phase III trial results and record product sales and earnings," said Arthur D. Levinson,

 

- 1 -


 

Ph.D., Genentech's chairman and chief executive officer. "We are pleased with our continued strong financial results as we enter the last quarter of our 5x5 program."

"For the full year 2005, we are currently expecting year-over-year non-GAAP earnings per share growth of approximately 50 percent," said David Ebersman, senior vice president and chief financial officer.

Note:  Genentech's non-GAAP net income and non-GAAP earnings per share exclude recurring charges related to the 1999 Roche redemption of Genentech's stock and litigation-related special items. The differences in non-GAAP and GAAP numbers are reconciled in the tables below and on www.gene.com. All share and per share amounts reflect the May 2004 two-for-one split of Genentech common stock.

Product Sales

"We are very proud of the strong bio-oncology business that we have built; for the first time in Genentech's history, quarterly oncology U.S. product sales topped one billion dollars," said Ian T. Clark, senior vice president, Commercial Operations. "While our policies only allow our sales force to promote our products for on-label usage, we see increasing use of Avastin in other cancer areas outside of the approved indication of first-line metastatic colorectal cancer, and of Herceptin in the adjuvant setting, also an unapproved use."

For the three months ended September 30, 2005:

  • Total product sales, comprised of U.S. product sales and product sales to collaborators (primarily ex-U.S. sales), increased 44 percent to $1,451.0 million from $1,005.5 million in the third quarter of 2004.
  • U.S. product sales increased 44 percent to $1,365.3 million, from U.S. product sales of $950.0 million in the third quarter of 2004.
  • U.S. sales of Avastin® (bevacizumab) increased 78 percent to $325.2 million, from U.S. sales of $183.0 million in the third quarter of 2004. Sequential quarter-over-quarter Avastin sales increased 32 percent from second quarter 2005 U.S. sales of $245.7 million.

 

- 2 -


 

  • U.S. sales of Herceptin® (Trastuzumab) increased 70 percent to $215.1 million, from U.S. sales of $126.3 million in the third quarter of 2004. Sequential quarter-over-quarter Herceptin sales increased 41 percent from second quarter 2005 U.S. sales of $152.4 million.
  • U.S. sales of Tarceva® (erlotinib) were $73.2 million. Sequential quarter-over-quarter Tarceva sales increased 4 percent from second quarter 2005 U.S. sales of $70.2 million. Tarceva was launched in the United States in November 2004.
  • U.S. sales of Rituxan® (Rituximab) increased 16 percent to $456.2 million, from U.S. sales of $393.0 million in the third quarter of 2004.
  • U.S. sales of Xolair® (Omalizumab) increased 51 percent to $81.6 million, from U.S. sales of $53.9 million in the third quarter of 2004.
  • U.S. sales of RAPTIVA® (efalizumab) increased 28 percent to $20.9 million, from U.S. sales of $16.3 million in the third quarter of 2004.
  • U.S. sales of legacy products, including growth hormone, cardiovascular products and Pulmozyme® (dornase alfa, recombinant) Inhalation Solution, increased 9 percent to $193.1 million, from U.S. sales of $177.6 million in the third quarter of 2004.
  • Product sales to collaborators increased 54 percent to $85.7 million, from sales of $55.5 million in the third quarter of 2004. The increase in product sales to collaborators primarily consisted of Avastin sales to Roche.

Royalties and Contract Revenues

  • Royalties increased 55 percent to $237.8 million from $153.9 million in the third quarter of 2004.
  • Contract revenues increased 46 percent to $63.0 million from $43.2 million in the third quarter of 2004.

 

- 3 -


 

Total Costs and Expenses

  • Cost of sales increased 39 percent to $230.1 million from $166.0 million in the third quarter of 2004, primarily due to higher product sales. Cost of sales as a percentage of product sales was 16 percent, compared to 17 percent in the third quarter of 2004.
  • Research and development (R&D) expenses increased 40 percent to $328.9 million from $234.1 million in the third quarter of 2004. R&D expenses as a percentage of operating revenues were 19 percent, comparable to the third quarter of 2004.
  • Marketing, general and administrative (MG&A) expenses increased 32 percent to $349.3 million from $264.6 million in the third quarter of 2004. MG&A expenses as a percentage of operating revenues were 20 percent, compared to 22 percent in the third quarter of 2004.
  • Collaboration profit-sharing expenses in the third quarter of 2005 increased 45 percent to $219.6 million from $151.9 million in the third quarter of 2004.

The unrestricted cash and investments portfolio totals approximately $4.1 billion as of September 30, 2005. Among other items, the cash balance reflects the receipt of $2 billion from the company's July 2005 debt offering and the use of approximately $929 million related to share repurchase activity in the third quarter. Also in the third quarter, the company paid approximately $585 million to buy out two synthetic lease obligations associated with its Vacaville and South San Francisco facilities.

Clinical Development

"We are making good progress in our efforts with the FDA to establish our filing timelines. We completed two sBLAs for Rituxan in the past quarter and plan to submit additional filings for Lucentis, Herceptin, Rituxan and Avastin within the next nine months," said Susan D. Hellmann, M.D., M.P.H., president of Product Development. "We plan to file sBLAs for Avastin in first-line non-squamous, non-small cell lung cancer and in first-line metastatic breast cancer during the first half of 2006."

 

- 4 -


 

Genentech anticipates filing a supplemental Biologics License Application (sBLA) in the first quarter of 2006 for Herceptin in the adjuvant setting based on data from U.S. studies. Genentech announced that, in addition to initiating the Phase III study of Avastin in first-line metastatic ovarian cancer, it completed enrollment in both the Phase I/II second-generation Anti-CD20 study in rheumatoid arthritis and the Phase I BR3-Fc study in rheumatoid arthritis.

Other Company Activity

The company provided additional information on the pending reexamination of the Cabilly, et al. U.S. Patent No. 6,331,415 (Cabilly patent). Genentech estimates that the process leading up to a final Office action or a notice of intent to issue a reexamination certificate from the U.S. Patent and Trademark Office may take from two to 12 months and that any appeals process may take several years. The overall net pre-tax income to Genentech from revenues and expenses related to the Cabilly patent was approximately $20 million for the third quarter of 2005, or approximately $0.01 per share. Genentech believes that the third quarter 2005 Cabillly-related pre-tax income figure represents approximately one-quarter of the full year's expected results, excluding the effects of a one-time licensee payment related to 2004 sales that was recorded in the first quarter of 2005.

In September 2005 the FDA granted approval for the manufacture of Rituxan bulk drug substance at Lonza's Portsmouth, New Hampshire production facility.

Webcast:

Genentech will be offering a live webcast of a discussion by Genentech management of the earnings and other business results on Monday, October 10, 2005, 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 October 24, 2005. A telephonic audio replay of the webcast will be available beginning at 5:15 p.m. PT on October 10, 2005 through 5:15 p.m. PT on October 17, 2005. Access numbers for this replay are: 1-800-642-1687 (U.S./Canada) and 1-706-645-9291 (international); conference ID number is 9678548.

 

- 5 -


 

About Genentech:

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 directly in the United States and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is traded on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.

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 the timeframe of potential FDA filings for Lucentis, Herceptin, Rituxan and Avastin; growth in non-GAAP EPS for 2005; and expected 2005 Cabilly-related income. Actual results could differ materially. Among other things, the timeframe for potential FDA filings could be affected by product safety, efficacy or manufacturing issues, additional time requirements to achieve study endpoints or for data analysis or filing preparation, need for additional clinical studies, and FDA actions or delays; and Cabilly-related income could be affected by sales growth of our licensees' products and our own products, the outcome of the re-examination or other related legal proceedings, and fluctuations in tax rates; the growth of new oncology products and indications may be affected by variables such as demand, penetration, reimbursement and duration of use; and non-GAAP EPS growth could be affected by all of the foregoing and by failure to receive FDA approv al; competition, pricing, the ability to supply product, product withdrawals, new product approvals and launches, achieving sales revenue consistent with internal forecasts, unanticipated expenses such as litigation or legal settlement expenses or equity securities write-downs, costs of sales, R&D expenses, fluctuations in royalties and contract revenues, and fluctuations in interest rates. Genentech disclaims, and does not undertake, any obligation to update or revise any forward-looking statements in this press release.

# # #

 

- 6 -


 

GENENTECH, INC.
CONSOLIDATED STATEMENTS OF INCOME DATA
(in thousands, except per share amounts)
(unaudited)

   

Three Months
Ended September 30,

   

2005

 

2004

   

GAAP(1)

 

Difference

 

Non-GAAP(2)

 

GAAP(1)

 

Difference

 

Non-GAAP(2)

Revenues:

                                 

   Product sales

$

1,450,979 

       

$

1,450,979 

 

$

1,005,511 

       

$

1,005,511 

   Royalties

 

237,777 

         

237,777 

   

153,942 

         

153,942 

   Contract revenue

 

63,066 

         

63,066 

   

43,191 

         

43,191 

      Total operating revenues

 

1,751,822 

         

1,751,822 

   

1,202,644 

         

1,202,644 

Costs and expenses:

                                 

   Cost of sales

 

230,127 

         

230,127 

   

165,990 

         

165,990 

   Research and development

 

328,850 

         

328,850 

   

234,086 

         

234,086 

   Marketing, general and administrative

 

349,323 

         

349,323 

   

264,648 

         

264,648 

   Collaboration profit sharing

 

219,591 

         

219,591 

   

151,894 

         

151,894 

   Recurring charges related to redemption

 

27,191 

 

$

(27,191)

(3)

 

   

34,534 

 

$

(34,534)

(3)

 

   Special items:  litigation-related

 

13,507 

   

(13,507)

(4)

 

   

13,419 

   

(13,419)

(4)

 

      Total costs and expenses

 

1,168,589 

   

(40,698)

   

1,127,891 

   

864,571 

   

(47,953)

   

816,618 

Operating margin

 

583,233 

   

40,698 

   

623,931 

   

338,073 

   

47,953 

   

386,026 

Other income, net(5)

 

22,391 

   

-  

   

22,391 

   

23,510 

   

-  

   

23,510 

Income before taxes

 

605,624 

   

40,698 

   

646,322 

   

361,583 

   

47,953 

   

409,536 

Income tax provision

 

246,211 

   

16,280 

   

262,491 

   

130,709 

   

19,181 

   

149,890 

Net income

$

359,413 

 

$

24,418 

 

$

383,831 

 

$

230,874 

 

$

28,772 

 

$

259,646 

Earnings per share:

                                 
 

Basic

$

0.34 

 

$

0.02 

 

$

0.36 

 

$

0.22 

 

$

0.03 

 

$

0.25 

 

Diluted

$

0.33 

 

$

0.02 

 

$

0.35 

 

$

0.21 

 

$

0.03 

 

$

0.24 

Weighted average shares used to compute
   earnings per share:

                                 

Basic

 

1,060,539 

         

1,060,539 

   

1,055,140 

         

1,055,140 

Diluted

 

1,086,964 

         

1,086,964 

   

1,077,093 

         

1,077,093 

___________________

(1)

 

Reflects operating results in accordance with U.S. generally accepted accounting principles (or GAAP).

(2)

 

Non-GAAP amounts exclude litigation-related special items and recurring charges related to the 1999 redemption of Genentech's Special Common Stock, net of tax effects.

(3)

 

Represents the amortization of other intangible assets related to the 1999 redemption of Genentech's Special Common Stock.

(4)

 

Represents accrued interest and bond costs in Q3 2005 and 2004 related to the City of Hope trial judgment.

(5)

 

"Other income, net" includes interest income, interest expense, net realized gains from the sale of certain biotechnology equity securities and write-downs for other-than-temporary impairments in the fair value of certain biotechnology debt and equity securities. For further detail, refer to our web site at www.gene.com.

     
   

2005 Reconciliation of GAAP and Non-GAAP EPS
Our 2005 non-GAAP EPS estimate does not include recurring charges related to the 1999 redemption of our stock by Roche, which are estimated to be approximately $123 million on a pretax basis in 2005. In addition, the 2005 non-GAAP EPS estimate does not include litigation-related special items for accrued interest and associated bond costs on the City of Hope judgment and net amounts paid on other litigation settlements, which were approximately $44 million through the third quarter of 2005 and currently estimated to be approximately $58 million on a pretax basis in 2005. Our 2005 GAAP EPS would include the redemption-related recurring charges and the litigation-related special items as well as any other potential special charges related to existing or future litigation or its resolution, or changes in accounting principles, all of which may be significant.

 

- 7 -


 

GENENTECH, INC.
CONSOLIDATED STATEMENTS OF INCOME DATA
(in thousands, except per share amounts)
(unaudited)

   

Nine Months
Ended September 30,

   

2005

 

2004

   

GAAP(1)

 

Difference

 

Non-GAAP(2)

 

GAAP(1)

 

Difference

 

Non-GAAP(2)

Revenues:

                                 

   Product sales

$

3,911,095 

       

$

3,911,095 

 

$

2,682,577 

       

$

2,682,577 

   Royalties

 

670,014 

         

670,014 

   

459,899 

         

459,899 

   Contract revenue

 

159,170 

         

159,170 

   

163,381 

         

163,381 

      Total operating revenues

 

4,740,279 

         

4,740,279 

   

3,305,857 

         

3,305,857 

Costs and expenses:

                                 

   Cost of sales

 

750,649 

         

750,649 

   

467,153 

         

467,153 

   Research and development

 

850,215 

         

850,215 

   

637,317 

         

637,317 

   Marketing, general and administrative

 

1,021,174 

         

1,021,174 

   

788,616 

         

788,616 

   Collaboration profit sharing

 

594,666 

         

594,666 

   

423,546 

         

423,546 

   Recurring charges related to redemption

 

96,155 

 

$

(96,155)

(3)

 

   

110,952 

 

$

(110,952)

(3)

 

   Special items:  litigation-related

 

44,291 

   

(44,291)

(4)

 

   

40,276 

   

(40,276)

(4)

 

      Total costs and expenses

 

3,357,150 

   

(140,446)

   

3,216,704 

   

2,467,860 

   

(151,228)

   

2,316,632 

Operating margin

 

1,383,129 

   

140,446 

   

1,523,575 

   

837,997 

   

151,228 

   

989,225 

Other income, net(5)

 

70,290 

   

   

70,290 

   

61,274 

   

   

61,274 

Income before taxes

 

1,453,419 

   

140,446 

   

1,593,865 

   

899,271 

   

151,228 

   

1,050,499 

Income tax provision

 

513,666 

   

56,178 

   

569,844 

   

321,040 

   

60,491 

   

381,531 

Net income

$

939,753 

 

$

84,268 

 

$

1,024,021 

 

$

578,231 

 

$

90,737 

 

$

668,968 

Earnings per share:

                                 
 

Basic

$

0.89 

 

$

0.08 

 

$

0.97 

 

$

0.55 

 

$

0.08 

 

$

0.63 

 

Diluted

$

0.87 

 

$

0.08 

 

$

0.95 

 

$

0.53 

 

$

0.09 

 

$

0.62 

Weighted average shares used to compute
   earnings per share:

                                 

Basic

 

1,055,028 

         

1,055,028 

   

1,057,006 

         

1,057,006 

Diluted

 

1,080,921 

         

1,080,921 

   

1,082,081 

         

1,082,081 

___________________

(1)

 

Reflects operating results in accordance with U.S. generally accepted accounting principles (or GAAP).

(2)

 

Non-GAAP amounts exclude litigation-related special items and recurring charges related to the 1999 redemption of Genentech's Special Common Stock, net of tax effects.

(3)

 

Represents the amortization of other intangible assets related to the 1999 redemption of Genentech's Special Common Stock.

(4)

 

Represents accrued interest and bond costs in 2005 and 2004 related to the City of Hope trial judgment, and net amounts paid in 2005 related to other litigation settlements.

(5)

 

"Other income, net" includes interest income, interest expense, net realized gains from the sale of certain biotechnology equity securities and write-downs for other-than-temporary impairments in the fair value of certain biotechnology debt and equity securities. For further detail, refer to our web site at www.gene.com.

     
   

2005 Reconciliation of GAAP and Non-GAAP EPS
Our 2005 non-GAAP EPS estimate does not include recurring charges related to the 1999 redemption of our stock by Roche, which are estimated to be approximately $123 million on a pretax basis in 2005. In addition, the 2005 non-GAAP EPS estimate does not include litigation-related special items for accrued interest and associated bond costs on the City of Hope judgment and net amounts paid on other litigation settlements, which were approximately $44 million through the third quarter of 2005 and currently estimated to be approximately $58 million on a pretax basis in 2005. Our 2005 GAAP EPS would include the redemption-related recurring charges and the litigation-related special items as well as any other potential special charges related to existing or future litigation or its resolution, or changes in accounting principles, all of which may be significant.

 

- 8 -


 

GENENTECH, INC.
CONSOLIDATED BALANCE SHEETS DATA
(in thousands)
(unaudited)

     
     
 

September 30,

 

 

2005

 

2004

 

Selected balance sheet data:

           

Cash, cash equivalents and short-term investments

$

2,905,543 

 

$

1,760,164 

 

Accounts receivable - product sales, net

 

509,465 

   

548,555 

 

Accounts receivable - royalties, net

 

264,179 

   

193,650 

 

Accounts receivable - other, net

 

189,341 

   

143,622 

 

Inventories

 

621,389 

   

559,920 

 

Long-term marketable debt and equity securities

 

1,242,866 

   

1,310,422 

 

Property, plant and equipment, net

 

3,128,089 

   

1,922,313 

 

Goodwill

 

1,315,019 

   

1,315,019 

 

Other intangible assets

 

587,911 

   

677,049 

 

Long-term assets

 

1,030,842 

   

774,435 

 

Total assets

 

12,099,306 

   

9,408,360 

 

Total current liabilities

 

1,354,938 

   

1,106,656 

 

Total liabilities

 

4,376,048 

   

2,441,064 

 

Total stockholders' equity

 

7,723,258 

   

6,967,566 

 
             

Year-to-date:

           

Capital expenditures

$

1,106,930 

 

$

418,214 

 
             
             

Total GAAP(1) depreciation and amortization expense

 

275,632 

   

259,583 

 

   Less:  redemption related amortization expense(3)

 

(96,155)

   

(110,952)

 

Non-GAAP(2) depreciation and amortization expense

$

179,477 

 

$

148,631 

 

___________________

(1)

 

In accordance with U.S. generally accepted accounting principles (or GAAP).

(2)

 

Non-GAAP amounts exclude amortization of other intangible assets related to the 1999 redemption of Genentech's Special Common Stock.

(3)

 

Represents the amortization of other intangible assets related to the 1999 redemption of Genentech's Special Common Stock.

 

- 9 -


 

GENENTECH, INC.
NET PRODUCT SALES DETAIL
(in thousands)
(unaudited)

     
 

Three Months
Ended September 30,

 

 

2005

 

2004

 

Net U.S. Product Sales

           

   Rituxan

$

456,227 

 

$

393,000 

 

   Herceptin

 

215,148 

   

126,300 

 

   Avastin

 

325,156 

   

183,003 

 

   Growth Hormone

 

88,585 

   

84,931 

 

   Thrombolytics

 

57,903 

   

52,867 

 

   Pulmozyme

 

46,593 

   

39,816 

 

   Xolair

 

81,550 

   

53,856 

 

   Raptiva

 

20,887 

   

16,265 

 

   Tarceva

 

73,222 

   

 

      Total U.S. product sales

 

1,365,271 

   

950,038 

 
             

Net product sales to collaborators

 

85,708 

   

55,473 

 

      Total Product Sales

$

1,450,979 

 

$

1,005,511 

 

     
 

Nine Months
Ended September 30,

 

 

2005

 

2004

 

Net U.S. Product Sales

           

   Rituxan

$

1,347,125 

 

$

1,144,813 

 

   Herceptin

 

497,205 

   

352,996 

 

   Avastin

 

773,695 

   

354,134 

 

   Growth Hormone

 

275,570 

   

256,896 

 

   Thrombolytics

 

160,105 

   

147,133 

 

   Pulmozyme

 

137,482 

   

114,340 

 

   Xolair

 

227,183 

   

127,332 

 

   Raptiva

 

58,803 

   

35,971 

 

   Tarceva

 

190,993 

   

 

      Total U.S. product sales

 

3,668,161 

   

2,533,615 

 
             

Net product sales to collaborators

 

242,934 

   

148,962 

 

      Total Product Sales

$

3,911,095 

 

$

2,682,577 

 

 

- 10 -


 

EX-99.2 3 dna-8kex99_2.htm GENENTECH, INC. - EXHIBIT 99.2 Genentech Inc. - Exhibit 99.2

EXHIBIT 99.2

 

GENENTECH, INC.
CONSOLIDATED STATEMENTS OF INCOME DATA
(in thousands, except per share amounts)
(unaudited)

               
               
 

Three Months
Ended September 30,

 

   

2005

     

2004

 

Revenues:

             

   Product sales

$

1,450,979 

   

$

1,005,511 

 

   Royalties

 

237,777 

     

153,942 

 

   Contract revenue

 

63,066 

     

43,191 

 

      Total operating revenues

 

1,751,822 

     

1,202,644 

 
               

Costs and expenses:

             

   Cost of sales

 

230,127 

     

165,990 

 

   Research and development

 

328,850 

     

234,086 

 

   Marketing, general and administrative

 

349,323 

     

264,648 

 

   Collaboration profit sharing

 

219,591 

     

151,894 

 

   Recurring charges related to redemption

 

27,191 

     

34,534 

 

   Special items:  litigation-related

 

13,507 

     

13,419 

 

      Total costs and expenses

 

1,168,589 

     

864,571 

 
               

Operating margin

 

583,233 

     

338,073 

 
               

Other income, net(1)

 

22,391 

     

23,510 

 
               

Income before taxes

 

605,624 

     

361,583 

 

Income tax provision

 

246,211 

     

130,709 

 

Net income

$

359,413 

   

$

230,874 

 

               

Earnings per share:

             

      Basic

$

0.34 

   

$

0.22 

 

      Diluted

$

0.33 

   

$

0.21 

 

               

Weighted average shares used to compute earnings per share:

             

      Basic

 

1,060,539 

     

1,055,140 

 

      Diluted

 

1,086,964 

     

1,077,093 

 

___________________

(1)

 

"Other income, net" includes interest income, interest expense, net realized gains from the sale of certain biotechnology equity securities and write-downs for other-than-temporary impairments in the fair value of certain biotechnology debt and equity securities. For further detail, refer to our web site at www.gene.com.

 

- 1 -


 

GENENTECH, INC.
CONSOLIDATED STATEMENTS OF INCOME DATA
(in thousands, except per share amounts)
(unaudited)

               
               
 

Nine Months
Ended September 30,

 

   

2005

     

2004

 

Revenues:

             

   Product sales

$

3,911,095 

   

$

2,682,577 

 

   Royalties

 

670,014 

     

459,899 

 

   Contract revenue

 

159,170 

     

163,381 

 

      Total operating revenues

 

4,740,279 

     

3,305,857 

 
               

Costs and expenses:

             

   Cost of sales

 

750,649 

     

467,153 

 

   Research and development

 

850,215 

     

637,317 

 

   Marketing, general and administrative

 

1,021,174 

     

788,616 

 

   Collaboration profit sharing

 

594,666 

     

423,546 

 

   Recurring charges related to redemption

 

96,155 

     

110,952

 

   Special items:  litigation-related

 

44,291 

     

40,276 

 

      Total costs and expenses

 

3,357,150 

     

2,467,860 

 
               

Operating margin

 

1,383,129 

     

837,997 

 
               

Other income, net(1)

 

70,290 

     

61,274 

 
               

Income before taxes

 

1,453,419 

     

899,271 

 

Income tax provision

 

513,666 

     

321,040 

 

Net income

$

939,753 

   

$

578,231 

 

               

Earnings per share:

             

      Basic

$

0.89 

   

$

0.55 

 

      Diluted

$

0.87 

   

$

0.53 

 

               

Weighted average shares used to compute earnings per share:

             

      Basic

 

1,055,028 

     

1,057,006 

 

      Diluted

 

1,080,921 

     

1,082,081 

 

___________________

(1)

 

"Other income, net" includes interest income, interest expense, net realized gains from the sale of certain biotechnology equity securities and write-downs for other-than-temporary impairments in the fair value of certain biotechnology debt and equity securities. For further detail, refer to our web site at www.gene.com.

 

- 2 -


GENENTECH, INC.
CONSOLIDATED BALANCE SHEETS DATA
(in thousands)
(unaudited)

     
     
 

September 30,

 

 

2005

 

2004

 

Selected balance sheet data:

           

Cash, cash equivalents and short-term investments

$

2,905,543 

 

$

1,760,164 

 

Accounts receivable - product sales, net

 

509,465 

   

548,555 

 

Accounts receivable - royalties, net

 

264,179 

   

193,650 

 

Accounts receivable - other, net

 

189,341 

   

143,622 

 

Inventories

 

621,389 

   

559,920 

 

Long-term marketable debt and equity securities

 

1,242,866 

   

1,310,422 

 

Property, plant and equipment, net

 

3,128,089 

   

1,922,313 

 

Goodwill

 

1,315,019 

   

1,315,019 

 

Other intangible assets

 

587,911 

   

677,049 

 

Long-term assets

 

1,030,842 

   

774,435 

 

Total assets

 

12,099,306 

   

9,408,360 

 

Total current liabilities

 

1,354,938 

   

1,106,656 

 

Total liabilities

 

4,376,048 

   

2,441,064 

 

Total stockholders' equity

 

7,723,258 

   

6,967,566 

 
             

Year-to-date:

           

Capital expenditures

$

1,106,930 

 

$

418,214 

 
             
             

Total depreciation and amortization expense

 

275,632 

   

259,583 

 

 

- 3 -


 

GENENTECH, INC.
NET PRODUCT SALES DETAIL
(in thousands)
(unaudited)

     
 

Three Months
Ended September 30,

 

 

2005

 

2004

 

Net U.S. Product Sales

           

   Rituxan

$

456,227 

 

$

393,000 

 

   Herceptin

 

215,148 

   

126,300 

 

   Avastin

 

325,156 

   

183,003 

 

   Growth Hormone

 

88,585 

   

84,931 

 

   Thrombolytics

 

57,903 

   

52,867 

 

   Pulmozyme

 

46,593 

   

39,816 

 

   Xolair

 

81,550 

   

53,856 

 

   Raptiva

 

20,887 

   

16,265 

 

   Tarceva

 

73,222 

   

 

      Total U.S. product sales

 

1,365,271 

   

950,038 

 
             

Net product sales to collaborators

 

85,708 

   

55,473 

 

      Total Product Sales

$

1,450,979 

 

$

1,005,511 

 

     
 

Nine Months
Ended September 30,

 

 

2005

 

2004

 

Net U.S. Product Sales

           

   Rituxan

$

1,347,125 

 

$

1,144,813 

 

   Herceptin

 

497,205 

   

352,996 

 

   Avastin

 

773,695 

   

354,134 

 

   Growth Hormone

 

275,570 

   

256,896 

 

   Thrombolytics

 

160,105 

   

147,133 

 

   Pulmozyme

 

137,482 

   

114,340 

 

   Xolair

 

227,183 

   

127,332 

 

   Raptiva

 

58,803 

   

35,971 

 

   Tarceva

 

190,993 

   

 

      Total U.S. product sales

 

3,668,161 

   

2,533,615 

 
             

Net product sales to collaborators

 

242,934 

   

148,962 

 

      Total Product Sales

$

3,911,095 

 

$

2,682,577 

 

 

- 4 -


 

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