Wednesday, Jul 11, 2001
Genentech Reports 33 Percent Increase in Product Sales for Second Quarter
28 Percent Increase in Net Income and 27 Percent Increase in Earnings Per Share, Exclusive of Impact of Redemption
South San Francisco, Calif. -- July 11, 2001 -- Genentech, Inc. (NYSE: DNA) today announced a 28 percent increase in net income and a 27 percent increase in earnings per share1 driven by a 33 percent increase in product sales for the second quarter of 2001, exclusive of the ongoing impact of the 1999 redemption of Genentech's Special Common Stock and related accounting treatment.2
For the three months ended June 30, 2001:
- Net income for the second quarter of 2001 increased 28 percent to $101.5 million, compared to $79.6 million for the second quarter of 2000, exclusive of the ongoing impact of the 1999 redemption of Genentech's Special Common Stock and related accounting treatment.
- Earnings per share for the second quarter of 2001 increased 27 percent to 19 cents per share, compared to 15 cents per share for the second quarter of 2000, exclusive of the ongoing impact of the 1999 redemption of Genentech's Special Common Stock and related accounting treatment.
- Due to recurring charges related to the redemption, the company recorded second quarter net income of $38.6 million, or net income of 7 cents per share, as compared to a net loss of $12.9 million, or a net loss of 2 cents per share, in the second quarter of 2000.
- Revenues for the second quarter of 2001 increased 24 percent to $515.9 million from $415.8 million in the second quarter of 2000. This revenue growth was driven primarily by sales of Genentech's BioOncology products, Rituxan® (Rituximab) and Herceptin® (Trastuzumab), and growth hormone. Total product sales increased 33 percent in the second quarter of 2001 to $410.3 million from $309.4 million in the second quarter of 2000.
"Our solid second-quarter performance reflects our ability to drive strong sales and earnings and is directly in line with our corporate strategy for growth," said Arthur D. Levinson, Ph.D., Genentech's chairman and chief executive officer. "Our oncology products, Rituxan and Herceptin, continued to generate significant sales and met our business objectives for the quarter. In May, we were able to further establish Genentech as a leader in oncology with an expanded label approval for Rituxan and numerous presentations on our oncology products at the annual meeting of the American Society of Clinical Oncology. During the quarter we also announced initial positive results from the first of two pivotal Phase III studies of Xanelim for psoriasis. In addition, despite yesterday's announcement regarding a delay in Xolair approval, we plan to move forward with this important product."
Product Sales
Marketed products sales increased 33 percent in the second quarter of 2001 to $410.3 million from $309.4 million in the second quarter of 2000.
Rituxan sales in the second quarter of 2001 increased 83 percent to $187.7 million from $102.8 million in the second quarter of 2000. This sales increase is due primarily to increased market penetration for the treatment of non-Hodgkin's lymphoma.
Herceptin sales in the second quarter of 2001 increased 18 percent to $78.8 million compared to $66.7 million in the second quarter of 2000. Since launch, an increase in the penetration into the metastatic breast cancer market has contributed to a positive sales trend and consistent quarter-over-quarter growth in the United States.
Combined sales of Genentech's two cardiovascular products, Activase® (Alteplase, recombinant) and TNKase™ (Tenecteplase), during the second quarter of 2001 decreased 9 percent to $51.6 million compared to $56.8 million in the second quarter of 2000.
Growth hormone sales during the second quarter of 2001 increased 25 percent to $62.5 million compared to $49.9 million in the second quarter of 2000.
Pulmozyme® (dornase alfa) Inhalation Solution sales decreased 13 percent to $28.1 million in the second quarter of 2001 compared to $32.3 million in the second quarter of 2000.
Total Costs and Expenses
Costs and expenses increased as anticipated in the second quarter of 2001 as compared to the second quarter of 2000.
Research and development (R&D) expenses increased in the second quarter of 2001 to $123.5 million compared to $115.6 million in 2000. R&D expenses as a percent of revenues in the second quarter of 2001 were 24 percent, compared to approximately 28 percent in the second quarter of 2000. R&D expenses as a percent of revenues are expected to vary over the next several periods dependent on possible in-licensing agreements and as products progress through late-stage clinical trials.
Primarily due to the increase in product sales, cost of sales increased to $76.2 million in the second quarter of 2001 from $66.2 million, exclusive of expenses related to the redemption and push-down accounting in the second quarter of 2000.
Marketing, general and administrative (MG&A) expenses increased during the second quarter of 2001 to $107.8 million compared to $86.3 million in the second quarter of 2000. This increase was due to an increase in marketing and selling expenses in continuing support of Genentech's oncology products and legal expenses associated with patent litigation.
Collaboration profit-sharing expenses increased to $57.9 million in the second quarter of 2001 from $30.9 million in the second quarter of 2000. The increase was due primarily to increased Rituxan profit-sharing expense due to higher Rituxan sales.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. Fourteen of the currently approved biotechnology products stem from or are based on Genentech science. Genentech markets nine biotechnology products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
1All earnings (loss) per share data and number of shares reflect the stock split effective October 2000.
2The accounting treatment under U.S. Generally Accepted Accounting Principles (GAAP) requires Genentech to establish a new accounting basis for the company's assets and liabilities. This accounting treatment is the result of Roche's exercise of its option to redeem Genentech's Special Common Stock in June 1999. The company's new accounting basis is based on the cost of Roche's 1990 through 1997 purchases of Genentech shares and the redemption of Genentech's Special Common Stock on June 30, 1999. Roche's cost of acquiring Genentech was "pushed down" to Genentech and reflected on Genentech's financial statements beginning June 30, 1999. The effect of push-down accounting on Genentech's second quarter 2001 and 2000 consolidated statements of operations include recurring charges for the amortization of goodwill and other intangibles.
Webcast:
Genentech will be offering a live webcast of a discussion by Genentech management of the earnings and other business results on Wednesday, July 11, 2001 at 2:30pm PDT. The live webcast may be accessed on Genentech's website at http://www.gene.com. This webcast will also be available after the call via the website until close of business July 18, 2001. An audio replay of the webcast will be available beginning at 4:30pm PDT on July 11, 2001 until 4:30pm PDT July 18, 2001. Access numbers for this replay are: 1-800-633-8284 (domestic) and 1-858-587-5842 (international); passcode number is 19096046.
Genentech Business and Product Development Events in the Second Quarter, 2001
Marketed and Pipeline Product Events
BioOncology
- Rituxan (Rituximab): Announced FDA approval of a new label for Rituxan to include retreatment with Rituxan after a prior course of Rituxan therapy, initial treatment doubled from four to eight weekly infusions of Rituxan, and treatment of bulky disease (tumors greater than 10 centimeters) and some significant adverse reactions for patients with low-grade non-Hodgkin's lymphoma (NHL).
- Tarceva™ (OSI-774): With partners Roche and OSI Pharmaceuticals, presented positive results from a Phase II advanced refractory ovarian cancer trial of Tarceva at the 37th annual meeting of the American Society of Clinical Oncology (ASCO) in May. Also presented findings from three Phase II trials of Tarceva demonstrating encouraging anti-cancer activity and Tarceva's potential utility as a single agent for the treatment of patients with refractory non-small cell lung cancer (NSCLC) and head and neck cancer. The companies also initiated Phase II clinical trials in metastatic breast cancer.
- Avastin™ (Bevacizumab): Received fast-track approval status from the FDA for Avastin, or anti-VEGF, in combination with capecitabine (Xeloda®) for the potential treatment of metastatic breast cancer.
- Herceptin® (Trastuzumab): In May at ASCO, presented data from three studies demonstrating that FISH (fluorescence in situ hybridization) testing of tumor tissue for HER2 gene amplification appears to be an effective method for selecting women with HER2 positive metastatic breast cancer who are most likely to respond to Herceptin therapy.
- 2C4: Filed an investigational new drug application for 2C4 for the potential treatment of solid-tumor cancers.
Cardiovascular Medicine
- Tracleer™ (Bosentan): With partner Actelion Ltd., announced positive results for oral endothelin receptor antagonist Tracleer in a Phase III pulmonary arterial hypertension (PAH) study. The new data will supplement the United States and European marketing approval applications filed last year.
- Veletri™ (tezosentan): With partner Actelion Ltd., announced the second pivotal Phase III clinical trial of VeletriTM an intravenous dual endothelin receptor antagonist -- did not meet its primary objective of significantly improving symptoms (dyspnea, or shortness of breath) associated with acute heart failure.
- Cathflo™ Activase™ (Alteplase): Reported positive results of a large-scale Phase III study of safety of Cathflo Activase for treatment of occluded central venous catheters. Genentech reported positive results earlier this year of an efficacy study of Cathflo Activase, which is currently awaiting FDA approval.
- TNKase™ (Tenecteplase): With collaborators COR Therapeutics, Inc. and Boehringer Ingelheim, completed enrollment in the ASSENT III study of TNKase in combination with various regimens of anti-thrombotic agents for acute myocardial infarction (heart attack). The companies are on schedule to present findings at the annual meeting of the European Society of Cardiology in September.
- Anti-tissue factor: Moved anti-tissue factor into development for the potential treatment of acute coronary syndrome.
Opportunistic
- Xanelim™ (Efalizumab): With partner XOMA Ltd., presented initial positive results from the first of two pivotal Phase III studies of Xanelim for adults with moderate-to-severe plaque psoriasis at the Second Joint Meeting of the International Psoriasis Symposium and European Congress on Psoriasis held in San Francisco.
- Xolair™ (Omalizumab): With Novartis AG, announced the receipt of a Complete Response letter from the FDA for the license application for Xolair, filed on June 6, 2000. The letter requests additional preclinical and clinical data, as well as pharmacokinetic information. It is anticipated that the initial proposed label claim will likely be for adult allergic asthma. With the requirement of additional data, there will not be an FDA approval of Xolair in 2001. The exact timing of resubmission to the FDA will be dependent on the scope of the discussions with the FDA.
- Growth hormone: Reacquired from Schwarz Pharma the exclusive development and marketing rights for human growth hormone products Nutropin AQ® (somatropin, rDNA origin) and Nutropin Depot® [somatropin (rDNA origin) for depot suspension] in Europe and other countries outside the United States, Canada, China, and Japan. Genentech is actively looking for potential new partners for the ex-U.S. development for these products.
- INS365 and INS37217: Returned rights to INS365 Respiratory for chronic bronchitis and INS37217 Respiratory for cystic fibrosis and sinusitis to Inspire Pharmaceuticals, Inc.
Corporate Business Events
- Defeated patent infringement lawsuit brought by GlaxoSmithKline relating to Herceptin and Rituxan and obtained jury verdict that those products do not infringe and that Glaxo's patent claims are invalid.
- Successfully defended Genentech's European patent relating to immunoadhesin therapeutics against challenges filed by Biogen and Genetics institute.
- Named Thomas T. Thomas to Treasurer and David Ebersman to Senior Vice President, Product Operations.
GENENTECH, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three Months
Ended June 30,
-------------------------------------------------
2001 2000(2)
---------------------- ----------------------
Actual Pro Forma(1) Actual Pro Forma(1)
-------- --------- -------- ---------
Revenues:
Product sales $410,258 $410,258 $309,414 $309,414
Royalties 52,446 52,446 49,643 49,643
Contract and other 20,935 20,935 34,507 34,507
Interest 32,235 32,235 22,262 22,262
-------- -------- -------- --------
Total revenues 515,874 515,874 415,826 415,826
Costs and expenses:
Cost of sales 76,188 76,188 97,657 66,283
Research and development 123,448 123,448 115,563 115,563
Marketing, general and administrative 107,800 107,800 86,259 86,259
Collaboration profit sharing 57,908 57,908 30,897 30,897
Recurring charges related to redemption 81,490 - 98,072 -
Interest 1,345 1,345 1,240 1,240
-------- -------- -------- --------
Total costs and expenses 448,179 366,689 429,688 300,242
Income (loss) before taxes 67,695 149,185 (13,862) 115,584
Income tax provision (benefit) 29,047 47,739 (997) 36,025
-------- -------- -------- --------
Net income (loss) $ 38,648 $101,446 $(12,865) $ 79,559
======== ======== ======== ========
Earnings (loss) per share:
Basic $ 0.07 $ 0.19 $ (0.02) $ 0.15
======== ======== ======== ========
Diluted $ 0.07 $ 0.19 $ (0.02) $ 0.15
======== ======== ======== ========
Weighted average shares used to compute
earnings (loss) per share:
Basic 526,998 526,998 521,233 521,233
======== ======== ======== ========
Diluted 535,142 535,142 521,233 538,373
======== ======== ======== ========
(1) Pro Forma amounts exclude recurring charges related to the redemption, costs in 2000 related to the sale of inventory that was written up at the redemption and their related tax effects.
(2) The results for the quarter ended June 30, 2001 have been restated to reflect the adoption of the Securities and Exchange Commission's Staff Accounting Bulletin No. 101 on Revenue Recognition as of January 1, 2000.
GENENTECH, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Six Months
Ended June 30,
---------------------------------------------------
2001 2000(2)
------------------------ ----------------------
Actual Pro Forma(1) Actual Pro Forma(1)
---------- ---------- -------- ---------
Revenues:
Product sales $ 802,161 $ 802,161 $592,592 $592,592
Royalties 127,077 127,077 96,987 96,987
Contract and other 59,419 49,415 70,361 70,361
Interest 67,299 67,299 43,736 43,736
---------- ---------- -------- --------
Total revenues 1,055,956 1,045,952 803,676 803,676
Costs and expenses:
Cost of sales 159,984 159,984 203,792 129,140
Research and development 259,788 259,788 226,969 226,969
Marketing, general and administrative 235,719 235,719 169,872 169,872
Collaboration profit sharing 104,281 104,281 49,231 49,231
Recurring charges related to redemption 163,007 - 196,619 -
Interest 2,836 2,836 2,526 2,526
---------- ---------- -------- --------
Total costs and expenses 925,615 762,608 849,009 577,738
Income (loss) before taxes and cumulative
effect of accounting change 130,341 283,344 (45,333) 225,938
Income tax provision (benefit) 59,305 90,670 (7,858) 70,429
---------- ---------- -------- --------
Income (loss) before cumulative effect
of accounting change 71,036 192,674 (37,475) 155,509
Cumulative effect of accounting change,
net of tax (2)(3) (5,638) - (57,800) -
---------- ---------- -------- --------
Net income (loss) $ 65,398 $ 192,674 $(95,275) $155,509
========== ========== ======== ========
Earnings (loss) per share:
Basic: Earnings (loss) before cumulative
effect of accounting change $ 0.13 $ 0.37 $ (0.07) $ 0.30
Cumulative effect of accounting
change, net of tax (0.01) - (0.11) -
---------- ---------- -------- --------
Net earnings (loss) per share $ 0.12 $ 0.37 $ (0.18) $ 0.30
========== ========== ======== ========
Diluted: Earnings (loss) before cumulative
effect of accounting change $ 0.13 $ 0.36 $ (0.07) $ 0.29
Cumulative effect of accounting
change, net of tax (0.01) - (0.11) -
---------- ---------- -------- --------
Net earnings (loss) per share $ 0.12 $ 0.36 $ (0.18) $ 0.29
========== ========== ======== ========
Weighted average shares used to compute
earnings (loss) per share:
Basic 526,396 526,396 520,182 520,182
========== ========== ======== ========
Diluted 535,181 535,181 520,182 539,348
========== ========== ======== ========
(1) Pro Forma amounts exclude recurring charges related to the redemption, costs in 2000 related to the sale of inventory that was written up at the redemption and their related tax effects. In addition, pro forma excludes the cumulative effect of the changes in accounting principle net of tax, adopted in 2001 and 2000, and the changes in fair value of certain derivatives ($10.0 million) recorded in Q1 2001 under FAS 133.
(2) The results for the three- and six-months ended June 30, 2001 have been restated to reflect the adoption of the SEC's Staff Accounting Bulletin No. 101 on Revenue Recognition as of January 1, 2000, and the related cumulative effect of a change in accounting principle associated with contract revenues recognized in prior periods. The related deferred revenue is being recognized over the term of the agreements.
(3) Genentech adopted Statement of Financial Accounting Standard 133 (FAS 133) on Accounting for Derivative Instruments and Hedging Activities (FAS 133) on January 1, 2001, and recorded a cumulative effect of a change in accounting principle related to recording derivative instruments at fair value.
GENENTECH, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)
(unaudited)
June 30,
------------------------------
2001 2000
----------- -----------
Selected balance sheet data:
Cash and short-term investments $ 1,392,806 $ 766,451
Accounts receivable 272,680 262,140
Inventories 316,319 240,190
Long-term marketable securities 1,208,305 1,334,683
Property, plant and equipment, net 790,504 739,698
Goodwill 1,379,136 1,531,742
Other intangible assets 1,194,020 1,353,040
Other long-term assets 243,121 170,293
Total assets 6,893,108 6,541,493
Total current liabilities 561,448 288,910
Long-term debt - 149,692
Total liabilities 1,073,103 1,087,746
Total stockholders' equity 5,820,005 5,453,747
Year-to-date:
Capital expenditures 85,676 53,571
Pro forma depreciation and amortization expense 53,503 47,304
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