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

(650) 225-1034

 

http://www.gene.com

 

GENENTECH ANNOUNCES SECOND QUARTER 2005 RESULTS

-- Total Product Sales Grow 39 Percent; Non-GAAP Net Income Increases 63 Percent --

-- Nine FDA Filings Anticipated --

SOUTH SAN FRANCISCO, Calif. -- July 11, 2005 -- Genentech, Inc. (NYSE: DNA) today announced financial results for the second quarter of 2005. Key results for the second quarter of 2005 included:

  • Total product sales of $1,274.1 million, a 39 percent increase over product sales of $913.4 million in the second quarter of 2004
  • Operating revenues of $1,526.8 million, a 35 percent increase over operating revenues of $1,128.2 million in the second quarter of 2004
  • Non-GAAP earnings per share increase of 58 percent to $0.30 per share from $0.19 per share in the second quarter of 2004; GAAP earnings per share increase of 69 percent to $0.27 per share from $0.16 per share in the second quarter of 2004
  • Non-GAAP net income increase of 63 percent to $328.6 million from $201.8 million in the second quarter of 2004; GAAP net income increase of 73 percent to $296.2 million from $170.8 million in the second quarter of 2004

"Our recent clinical and financial successes are built on decades of rigorous efforts to continuously follow the science and focus on the patient. We have demonstrated continued strong growth this past quarter, achieving significant increases in product sales, revenues and earnings

 

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per share," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. "Moving forward, we remain focused on strong execution that will allow us to pursue breakthrough therapies and the achievement of our Horizon 2010 goals."

"We are currently expecting year-over-year non-GAAP earnings per share for 2005 to increase by greater than 35 percent, relative to 2004," 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

For the three months ended June 30, 2005:

  • Total product sales, comprised of U.S. product sales and product sales to collaborators (primarily ex-U.S. sales), increased 39 percent to $1,274.1 million from $913.4 million in the second quarter of 2004.
  • U.S. product sales increased 39 percent to $1,215.9 million from U.S. product sales of $872.5 million in the second quarter of 2004.
  • U.S. sales of Avastin™ (bevacizumab) increased 85 percent to $245.7 million, from U.S. sales of $133.0 million in the second quarter of 2004. Sequential quarter-over-quarter Avastin sales increased 21 percent from first quarter 2005 U.S. sales of $202.9 million.
  • U.S. sales of Tarceva™ (erlotinib) were $70.2 million. Sequential quarter-over-quarter Tarceva sales increased 47 percent from first quarter 2005 U.S. sales of $47.6 million. Tarceva was launched in the United States in November 2004.
  • U.S. sales of Rituxan® (Rituximab) increased 15 percent to $450.3 million, from U.S. sales of $390.0 million in the second quarter of 2004.
  • U.S. sales of Herceptin® (Trastuzumab) increased 29 percent to $152.4 million, from U.S. sales of $118.0 million in the second quarter of 2004.

 

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  • U.S. sales of Xolair® (Omalizumab) increased 84 percent to $80.4 million, from U.S. sales of $43.6 million in the second quarter of 2004.
  • U.S. sales of RAPTIVA® (efalizumab) increased 59 percent to $21.3 million, from U.S. sales of $13.4 million in the second quarter of 2004.
  • U.S. sales of legacy products, including growth hormone, cardiovascular products and Pulmozyme® (dornase alfa, recombinant) Inhalation Solution, increased 12 percent to $195.6 million, from U.S. sales of $174.5 million in the second quarter of 2004.
  • Product sales to collaborators increased 42 percent to $58.2 million, from sales of $40.9 million in the second quarter of 2004. Product sales to collaborators primarily consisted of shipments of Rituxan and Pulmozyme for the ex-U.S. markets and Enbrel for the U.S. market.

Royalties and Contract Revenues

  • Royalties increased 32 percent to $200.3 million from $151.9 million in the second quarter of 2004.
  • Contract revenues decreased 17 percent to $52.4 million from $62.9 million in the second quarter of 2004.

Total Costs and Expenses

  • Cost of sales increased 44 percent to $269.5 million from $186.7 million in the second quarter of 2004, primarily due to higher product sales and charges of $41.0 million to cancel certain manufacturing obligations. Cost of sales as a percentage of product sales was 21 percent compared to 20 percent in the second quarter of 2004.
  • Research and development (R&D) expenses increased 31 percent to $278.1 million from $212.9 million in the second quarter of 2004. R&D expenses as a percentage of operating revenues were 18 percent compared to 19 percent in the second quarter of 2004.
  • Marketing, general and administrative (MG&A) expenses increased 29 percent to $356.6 million from $276.7 million in the second quarter of 2004. MG&A expenses as a percentage of operating revenues decreased to 23 percent compared to 25 percent in the second quarter of 2004.

 

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  • Collaboration profit-sharing expenses in the second quarter of 2005 increased 37 percent to $198.8 million from $145.2 million in the second quarter of 2004. The growth in these expenses is attributable to higher Rituxan, Tarceva, and Xolair sales.
  • Genentech's income tax rate for the second quarter of 2005 decreased from the prior year and the prior quarter primarily as the result of a one-time benefit from recognizing additional R&D tax credits. The one-time benefit is based upon new regulations recently issued by the U.S. Department of Treasury that are favorable for Genentech.

Clinical Development

"I am tremendously pleased that our efforts to discover and develop potential therapies may change clinical practice and improve the lives of patients. We are actively working with the FDA to prioritize the nine potential filings relating to our significant Phase III trial results, while we continue to develop more than 30 projects in the pipeline primarily in our oncology and immunology focus areas," said Susan D. Hellmann, M.D., M.P.H., president of Product Development. "We currently anticipate filing Herceptin for adjuvant breast cancer in the first quarter of 2006 and expect to provide updates on filing timelines for Avastin data upon the completion of preliminary discussions with the FDA."

Genentech is preparing for potential U.S. Food and Drug Administration (FDA) filings for Avastin for second-line metastatic colorectal cancer; Avastin for first-line non-squamous non-small cell lung cancer; Avastin for metastatic breast cancer; Herceptin for adjuvant breast cancer; Herceptin in combination with Taxotere for first-line metastatic breast cancer; Lucentis in wet age-related macular degeneration; Rituxan for front-line aggressive non-Hodgkins lymphoma (NHL); Rituxan for front-line indolent/maintenance1 NHL; and Rituxan for rheumatoid arthritis in inadequate anti-TNF responders.

Genentech announced that in the second quarter of 2005 it began enrolling patients in several Phase III studies, including Rituxan in systemic lupus erythematosus, Avastin in prostate cancer, and combination Avastin and Tarceva in second-line non-small cell lung cancer. It also began enrollment in a Phase I study of a small molecule hedgehog antagonist in basal cell carcinoma in collaboration with Curis.

 

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The company also announced that it removed from the development pipeline Omnitarg as a single agent in breast and lung cancer. It continues to enroll the Phase II study of Omnitarg in combination with chemotherapy for ovarian cancer.

Genentech and Boehringer Ingelheim announced that they stopped early the ASSENT 4 PCI trial, a randomized, open-label Phase IIIb/IV clinical study of the single-bolus thrombolytic TNKase™/Metalyse® (tenecteplase) in combination with a planned percutaneous coronary intervention (PCI, also known as primary angioplasty/stenting) versus PCI alone in patients with large acute myocardial infarctions. The trial was stopped after an analysis of the 30-day data showed that the mortality rates in those treated with tenecteplase plus PCI were higher than in the PCI alone arm. Additional results from the study will be presented at the annual meeting of the European Society of Cardiology in Stockholm, Sweden in September 2005.

Executive Appointment

Patrick Y. Yang, Ph.D., senior vice president of Product Operations, will become a member of Genentech's Executive Committee.

Yang will continue to report to Levinson and will continue to be responsible for Manufacturing, Facilities, Engineering, Process Development and Supply Chain Management functions. He joined Genentech in 2003 as vice president, South San Francisco Manufacturing and Engineering.

Webcast:

Genentech will be offering a live webcast of a discussion by Genentech management of the earnings and other business results on Monday, July 11, 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 July 25, 2005. An audio replay of the webcast will be available beginning at 5:15 p.m. PT on July 11, 2005 through 5:15 p.m. PT on July 18, 2005. Access numbers for this replay are: 1-800-642-1687 (U.S./Canada) and 1-706-645-9291 (international); conference ID number is 7086252.

 

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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 nine potential FDA filings, the FDA filing timeframe for Herceptin in adjuvant breast cancer, achievement of Horizon 2010 goals and expected growth in non-GAAP EPS for 2005, and actual results could differ materially. Among other things, potential FDA filings, including the Herceptin filing timeframe, and our Horizon 2010 goals of adding programs into research and clinical development 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; our Horizon 2010 goal of bringing potential new products or indications to market could be affected by all of the foregoing and failure to receive FDA approval; our Horizon 2010 goals of becoming number one in U.S. oncology sales and building a leading immunology business could be affected by all of the foregoing and by competition, pricing, reimbursement, the ability to supply product, product withdrawals, new product approvals and launches and achieving sales revenue consistent with internal forecasts; and non-GAAP EPS growth, including our Horizon 2010 goal of non-GAAP EPS growth, could be affected by all of the foregoing and by unanticipated expenses such as litigation or legal settlement expenses or equity securities write-downs, cost of sales, R&D expenses, fluctuations in royalties and contract revenues, and

 

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fluctuations in tax and interest rates. Genentech disclaims, and does not undertake, any obligation to update or revise any forward-looking statements in this press release.

# # #

1  One area of concern for the FDA is the use of the term "maintenance." Genentech will be working toward a nomenclature that the FDA feels better describes this approach to treating patients with Rituxan.

______________________

 

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

   

Three Months
Ended June 30,

   

2005

 

2004

   

GAAP(1)

 

Difference

 

Non-GAAP(2)

 

GAAP(1)

 

Difference

 

Non-GAAP(2)

Revenues:

                                 

   Product sales

$

1,274,115 

       

$

1,274,115 

 

$

913,366 

       

$

913,366 

   Royalties

 

200,321 

         

200,321 

   

151,860 

         

151,860 

   Contract revenue

 

52,443 

         

52,443 

   

62,852 

         

62,852 

      Total operating revenues

 

1,526,879 

         

1,526,879 

   

1,128,078 

         

1,128,078 

Costs and expenses:

                                 

   Cost of sales

 

269,481 

         

269,481 

   

186,683 

         

186,683 

   Research and development

 

278,124 

         

278,124 

   

212,886 

         

212,886 

   Marketing, general and administrative

 

356,638 

         

356,638 

   

276,654 

         

276,654 

   Collaboration profit sharing

 

198,798 

         

198,798 

   

145,221 

         

145,221 

   Recurring charges related to redemption

 

34,482 

 

$

(34,482)

(3)

 

   

38,209 

 

$

(38,209)

(3)

 

   Special items:  litigation-related

 

19,527 

   

(19,527)

(4)

 

   

13,458 

   

(13,458)

(4)

 

      Total costs and expenses

 

1,157,050 

   

(54,009)

   

1,103,041 

   

873,111 

   

(51,667)

   

821,444 

Operating margin

 

369,829 

   

54,009 

   

423,838 

   

254,967 

   

51,667 

   

306,634 

Other income, net(5)

 

31,502 

   

   

31,502 

   

15,444 

   

   

15,444 

Income before taxes

 

401,331 

   

54,009 

   

455,340 

   

270,411 

   

51,667 

   

322,078 

Income tax provision

 

105,165 

   

21,603 

   

126,768 

   

99,640 

   

20,666 

   

120,306 

Net income

$

296,166 

 

$

32,406 

 

$

328,572 

 

$

170,771 

 

$

31,001 

 

$

201,772 

Earnings per share:

                                 
 

Basic

$

0.28 

 

$

0.03 

 

$

0.31 

 

$

0.16 

 

$

0.03 

 

$

0.19 

 

Diluted

$

0.27 

 

$

0.03 

 

$

0.30 

 

$

0.16 

 

$

0.03 

 

$

0.19 

Weighted average shares used to compute
   earnings per share:

                                 

Basic

 

1,057,564 

         

1,057,564 

   

1,060,619 

         

1,060,619 

Diluted

 

1,083,841 

         

1,083,841 

   

1,087,087 

         

1,087,087

___________________

(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 Q2 2005 and 2004 related to the City of Hope trial judgment, and amounts paid in Q2 2005 related to a litigation settlement.

(5)

 

"Other income, net" includes interest income and interest expense. In addition, "other income, net" includes 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 GAAP EPS is not estimable at this time. The 2005 GAAP EPS would 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 GAAP EPS would include litigation-related special charges for accrued interest and associated bond costs on the City of Hope judgment, which are currently estimated to be approximately $14 million per quarter on a pretax basis in 2005 until resolved. The 2005 non-GAAP EPS estimate does not include the redemption related recurring charges and the litigation-related special items or 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.

 

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

   

Six Months
Ended June 30,

   

2005

 

2004

   

GAAP(1)

 

Difference

 

Non-GAAP(2)

 

GAAP(1)

 

Difference

 

Non-GAAP(2)

Revenues:

                                 

   Product sales

$

2,460,117 

       

$

2,460,117 

 

$

1,677,066 

       

$

1,677,066 

   Royalties

 

432,236 

         

432,236 

   

305,957 

         

305,957 

   Contract revenue

 

96,104 

         

96,104 

   

120,190 

         

120,190 

      Total operating revenues

 

2,988,457 

         

2,988,457 

   

2,103,213 

         

2,103,213 

Costs and expenses:

                                 

   Cost of sales

 

520,522 

         

520,522 

   

301,163 

         

301,163 

   Research and development

 

521,364 

         

521,364 

   

403,231 

         

403,231 

   Marketing, general and administrative

 

671,852 

         

671,852 

   

523,968 

         

523,968 

   Collaboration profit sharing

 

375,075 

         

375,075 

   

271,652 

         

271,652 

   Recurring charges related to redemption

 

68,964 

 

$

(68,964)

(3)

 

   

76,418 

 

$

(76,418)

(3)

 

   Special items:  litigation-related

 

30,784 

   

(30,784)

(4)

 

   

26,857 

   

(26,857)

(4)

 

      Total costs and expenses

 

2,188,561 

   

(99,748)

   

2,088,813 

   

1,603,289 

   

(103,275)

   

1,500,014 

Operating margin

 

799,896 

   

99,748 

   

899,644 

   

499,924 

   

103,275 

   

603,199 

Other income, net(5)

 

47,899 

   

   

47,899 

   

37,765 

   

   

37,765 

Income before taxes

 

847,795 

   

99,748 

   

947,543 

   

537,689 

   

103,275 

   

640,964 

Income tax provision

 

267,455 

   

39,899 

   

307,354 

   

190,331 

   

41,310 

   

231,641 

Net income

$

580,340 

 

$

59,849 

 

$

640,189 

 

$

347,358 

 

$

61,965 

 

$

409,323 

Earnings per share:

                                 
 

Basic

$

0.55 

 

$

0.06 

 

$

0.61 

 

$

0.33 

 

$

0.06 

 

$

0.39 

 

Diluted

$

0.54 

 

$

0.05 

 

$

0.59 

 

$

0.32 

 

$

0.06 

 

$

0.38 

Weighted average shares used to compute
   earnings per share:

                                 

Basic

 

1,052,228 

         

1,052,228 

   

1,057,955 

         

1,057,955 

Diluted

 

1,076,519 

         

1,076,519 

   

1,084,618 

         

1,084,618 

___________________

(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 and interest expense. In addition, "other income, net" includes 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 GAAP EPS is not estimable at this time. The 2005 GAAP EPS would 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 GAAP EPS would include litigation-related special charges for accrued interest and associated bond costs on the City of Hope judgment, which are currently estimated to be approximately $14 million per quarter on a pretax basis in 2005 until resolved. The 2005 non-GAAP EPS estimate does not include the redemption related recurring charges and the litigation-related special items or 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.

 

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

     
     
 

June 30,

 

 

2005

 

2004

 

Selected balance sheet data:

           

Cash, cash equivalents and short-term investments

$

2,010,541 

 

$

1,619,134 

 

Accounts receivable - product sales, net

 

509,971 

   

445,076 

 

Accounts receivable - royalties, net

 

238,714 

   

189,513 

 

Accounts receivable - other, net

 

165,133 

   

136,593 

 

Inventories

 

600,863 

   

527,649 

 

Long-term marketable debt and equity securities

 

901,052 

   

1,414,663 

 

Property, plant and equipment, net

 

2,792,106 

   

1,740,423 

 

Goodwill

 

1,315,019 

   

1,315,019 

 

Other intangible assets

 

603,956 

   

710,644 

 

Long-term assets

 

998,673 

   

817,906 

 

Total assets

 

10,546,610 

   

9,083,774 

 

Total current liabilities

 

1,141,735 

   

862,201 

 

Total liabilities

 

2,566,605 

   

2,198,740 

 

Total stockholders' equity

 

7,980,005 

   

6,885,034 

 
             

Year-to-date:

           

Capital expenditures

$

729,810 

 

$

196,633 

 
             
             

Total GAAP(1) depreciation and amortization expense

 

181,454 

   

178,520 

 

   Less:  redemption related amortization expense(3)

 

(68,964)

   

(76,418)

 

Non-GAAP(2) depreciation and amortization expense

$

112,490 

 

$

102,102 

 

___________________

(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.

 

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

     
 

Three Months
Ended June 30,

 

 

2005

 

2004

 

Net US Sales:

           

   Rituxan

$

450,348 

 

$

390,005 

 

   Herceptin

 

152,427 

   

118,001 

 

   Avastin

 

245,685 

   

133,004 

 

   Growth Hormone

 

97,116 

   

88,000 

 

   Thrombolytics

 

51,635 

   

50,001 

 

   Pulmozyme

 

46,906 

   

36,509 

 

   Xolair

 

80,370 

   

43,623 

 

   Raptiva

 

21,271 

   

13,415 

 

   Tarceva

 

70,186 

   

 

      Total US Sales

$

1,215,944 

 

$

872,558 

 

             

Net Sales to Collaborators:

           

   Rituxan

$

32,013 

 

$

34,661 

 

   Herceptin

 

(1,767)

   

(319)

 

   Avastin

 

3,557 

   

 

   Growth Hormone

 

799 

   

413 

 

   Thrombolytics

 

1,663 

   

1,543 

 

   Pulmozyme

 

7,886 

   

4,457 

 

   Xolair

 

1,722 

   

53 

 

   Raptiva

 

3,629 

   

 

   Enbrel

 

8,669 

   

 

      Total Sales to Collaborators

$

58,171 

 

$

40,808 

 

      Total Net Product Sales

$

1,274,115 

 

$

913,366 

 

     
 

Six Months
Ended June 30,

 

 

2005

 

2004

 

Net US Sales:

           

   Rituxan

$

890,898 

 

$

751,813 

 

   Herceptin

 

282,057 

   

226,696 

 

   Avastin

 

448,540 

   

171,131 

 

   Growth Hormone

 

186,984 

   

171,965 

 

   Thrombolytics

 

102,202 

   

94,266 

 

   Pulmozyme

 

90,889 

   

74,524 

 

   Xolair

 

145,633 

   

73,476 

 

   Raptiva

 

37,916 

   

19,706 

 

   Tarceva

 

117,771 

   

 

      Total US Sales

$

2,302,890 

 

$

1,583,577 

 

             

Net Sales to Collaborators:

           

   Rituxan

$

65,063 

 

$

73,483 

 

   Herceptin

 

9,121 

   

4,449 

 

   Avastin

 

15,189 

   

 

   Growth Hormone

 

3,019 

   

1,918 

 

   Thrombolytics

 

4,666 

   

3,502 

 

   Pulmozyme

 

15,649 

   

9,874 

 

   Xolair

 

5,056 

   

263 

 

   Raptiva

 

11,099 

   

 

   Enbrel

 

28,365 

   

 

      Total Sales to Collaborators

$

157,227 

 

$

93,489 

 

      Total Net Product Sales

$

2,460,117 

 

$

1,677,066 

 

 

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